MRD evidence
What the studies show
Landmark papers an MRD reader should know, including trials that did not meet their aim. Numbers below are taken from the abstracts. Assay names are labels, not a ranking. The full list remains on Research. Multi-cancer early detection is on MCED.
Level 1
A prospective trial in which the ctDNA or MRD result assigns, withholds, or changes treatment. Randomized and single-arm adaptive trials both qualify. Positive and negative trials are listed.
Level 2
A large prospective observational cohort, or a correlative analysis from a phase 3 trial or other large study. The test informs prognosis or describes a treatment association. It does not assign therapy.
Level 3
A smaller cohort, a single-center series, a feasibility study, or an analytical validation. Useful for methods and early signals, not for changing practice on its own.
Must-know papers
- PositiveLevel 12022 · The New England Journal of Medicine
Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer.
Tie J, et al. PMID 35657320. doi 10.1056/NEJMoa2200075
DYNAMIC, a randomized trial in stage II colon cancer. Of 455 people, 302 had ctDNA-guided management and 153 had standard management. Adjuvant chemotherapy use was 15% versus 28%. Two-year recurrence-free survival was 93.5% versus 92.4%, meeting the non-inferiority margin.
- NegativeLevel 12025 · Nature Medicine
Circulating tumor DNA-guided adjuvant therapy in locally advanced colon cancer: the randomized phase 2/3 DYNAMIC-III trial.
Tie J, et al. PMID 41115959. doi 10.1038/s41591-025-04030-w
DYNAMIC-III, a randomized phase 2/3 trial in stage III colon cancer. Of 968 evaluable people, 702 (72.5%) were ctDNA-negative. Three-year recurrence-free survival was 87% if ctDNA-negative and 49% if positive. De-escalation in the negative group did not meet non-inferiority (85.3% versus 88.1%). Escalation in the positive group did not improve 2-year recurrence-free survival (51% versus 61%).
- PositiveLevel 22023 · Nature Medicine
Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer.
Kotani D, et al. PMID 36646802. doi 10.1038/s41591-022-02115-4
GALAXY, the observational arm of CIRCULATE-Japan, in 1,039 people with stage II–IV resectable colorectal cancer. Postsurgical ctDNA positivity at 4 weeks was associated with recurrence (HR 10.0) and was the strongest prognostic factor in stage II or III disease (HR 10.82).
- PositiveLevel 22022 · Clinical Cancer Research
Circulating Tumor DNA in Stage III Colorectal Cancer, beyond Minimal Residual Disease Detection, toward Assessment of Adjuvant Therapy Efficacy and Clinical Behavior.
Henriksen TV, et al. PMID 34625408. doi 10.1158/1078-0432.CCR-21-2404
Prospective series of 168 people with stage III colorectal cancer (1,204 plasma samples; Reinert is an author). Postoperative ctDNA detection predicted recurrence (HR 7.0). The assay used 16 patient-specific variants.
- PositiveLevel 22026 · NPJ Precision Oncology
Validation of a methylation-based, tissue-free MRD assay in colorectal cancer patients from the GALAXY study.
Nakamura Y, et al. PMID 41555007. doi 10.1038/s41698-026-01277-5
A tissue-free methylation assay (Latitude) was tested on 1,230 time points from 195 people in GALAXY. ctDNA positivity was associated with worse disease-free survival in the residual-disease window (HR 10.0) and in surveillance (HR 31.9).
- NegativeLevel 12026 · Nature Medicine
Post-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial.
Bando H, et al. PMID 42260101. doi 10.1038/s41591-026-04428-0
ALTAIR, a randomized phase 3 trial (NCT04457297). 243 people with resected colorectal cancer who were ctDNA-positive without radiographic disease were assigned to trifluridine/tipiracil or placebo. Median disease-free survival was 9.30 versus 5.55 months (HR 0.79, P = 0.107). The primary endpoint was not met.
- NegativeLevel 12026 · Nature Cancer
Circulating tumor DNA-guided de-escalation or escalation of adjuvant therapy in high-risk stage II and stage III colon cancer: the phase 2 PEGASUS trial.
Marsoni S, et al. PMID 42736431. doi 10.1038/s43018-026-01237-9
PEGASUS, a phase 2 ctDNA-guided trial. Of 135 people, 35 (26%) were ctDNA-positive after surgery. The primary endpoint, a 2-year relapse-free rate of at least 92% in the ctDNA-negative group, was not met (observed 88%).
Urine tumor DNA studies
From the utDNA catalog. Plasma ctDNA studies are labeled plasma. Conference abstracts stay labeled as abstracts. These figures are not a ranking.
Peer-reviewed
Detection and Surveillance of Bladder Cancer Using Urine Tumor DNA.
Dudley JC, Schroers-Martin J, Lazzareschi DV, Shi WY, Chen SB, Esfahani MS, Trivedi D, Chabon JJ, Chaudhuri AA, et al.; Alizadeh AA and Diehn M senior.
Cancer Discov 2019.
n: 67 healthy adults and 118 patients with early-stage bladder cancer
Pretreatment or surveillance, early-stage BLCA
Assay: uCAPP-Seq (utDNA CAPP-Seq), targeted high-throughput sequencing
- Median 6 mutations per patient; PLEKHS1 promoter mutations in 46%.
- Pretreatment detection 93% tumor-informed, 84% tumor-naive, 96% to 100% specificity.
- Surveillance: utDNA detected in 91% of patients who ultimately recurred; preceded clinical progression in 92% (median lead time 2.7 months in the full text).
- Outperformed UroVysion (P=0.02) and cytology and cystoscopy combined (P<=0.006); detected 100% of cytology-positive cases and 82% that cytology missed (abstract).
- Surveillance subset in full text: tumor-naive profiling detected 100% of recurrent cases with positive cytology (n=14) and 73.9% with negative cytology (n=23).
Peer-reviewed
Urine cell-free RNA for bladder cancer detection and treatment response prediction.
Liu KJ, Shi WY, Nesselbush MC, Phillips NA, Mach KE, et al.; Alizadeh AA, Liao JC, and Diehn M senior.
Nat Med. Published 2 October 2026. Open access on the Nature page.
n: 683 urine samples from patients with cancer and controls
Detection, MRD, and BCG-versus-chemotherapy response prediction in bladder cancer; also transcripts from prostate and kidney cancers noted.
Assay: uRARE-seq (urine random priming and affinity capture of cell-free RNA fragments for enrichment analysis by sequencing)
- 95% sensitivity at 90% specificity for detecting localized bladder cancer.
- Outperformed urine tumor DNA analysis and was unaffected by field-effect mutations.
- Sensitively detected MRD and distinguished complete molecular responses after surgery from those after BCG.
- Pretreatment urine from BCG complete responders enriched for T-cell and other immune signatures; nonresponders showed higher proliferation-related gene expression.
- In pretreatment urine from 114 patients, a biomarker predicting BCG versus chemotherapy response had AUC 0.93 and was strongly associated with recurrence risk.
- Authors state prospective studies are needed to assess clinical utility.
Peer-reviewed
Field-effect-informed urine liquid biopsy for bladder cancer.
Shi WY, Liu KJ, Esfahani MS, Mach KE et al. Cell 2026;189(4):1024-1038.e9.
n: 261 serial specimens from 61 NMIBC patients (validation); plus training and control analyses described in field_cancerization
Intermediate- or high-risk NMIBC, TURBT and adjuvant BCG
Assay: Field-effect-informed (RePhyNERX-enhanced) uCAPP-Seq, tumor-informed
Peer-reviewed
clinical trial (not utDNA; context)
Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer.
Powles T, Catto JWF, Galsky MD, et al., including van der Heijden MS, NIAGARA Investigators.
N Engl J Med 2024;391(19):1773-1786.
n: 1063 (533 durvalumab, 530 comparison)
Phase 3, cisplatin-eligible MIBC
Assay: n/a (clinical end points)
- 24-month EFS 67.8% vs 59.8%, HR 0.68 (0.56-0.82), P<0.001.
- 24-month OS 82.2% vs 75.2%, HR 0.75 (0.59-0.93), P=0.01.
co-author
Conference abstract
plasma ctDNA (not utDNA)
Circulating tumor DNA (ctDNA) in patients with MIBC who received perioperative durvalumab in NIAGARA.
J Clin Oncol 2025;43(16_suppl):4503.
n: BEP 462 of 1063 (237 D, 225 C)
Exploratory plasma ctDNA in NIAGARA
Assay: Signatera, tumor-informed (Natera)
- Baseline ctDNA+ 57% (260/460), pre-RC 22% (94/422).
- Clearance baseline to pre-RC: 41% durvalumab vs 31% comparator.
- Non-pCR 97% (86/89) if pre-RC ctDNA+.
- Post-RC ctDNA+ 9% (31/345).
- EFS benefit of durvalumab reported in both baseline ctDNA+ and ctDNA- groups.
Conference abstract
utDNA and plasma ctDNA
Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients with MIBC who received perioperative durvalumab in NIAGARA.
J Clin Oncol 2026;44(7_suppl):636. ASCO GU 2026. Conference abstract; not a full paper.
n: BEP 265 of 1063 (25%; 134 D, 131 C); utDNA at BL n=205, pre-RC n=183
Exploratory utDNA + ctDNA in NIAGARA, cisplatin-eligible MIBC, pre-cystectomy
Assay: Personalized Signatera (Natera), same framework as the plasma test
- Lower baseline utDNA associated with longer EFS (low vs high HR 0.65, 95% CI 0.40-1.04).
- utDNA+ rate 85% at baseline, 55% pre-RC.
- utDNA clearance associated with longer EFS (HR 0.24, 95% CI 0.09-0.62); clearance 39% vs 27% (12 points higher with durvalumab).
- Pre-RC utDNA-: pCR 72% (55/76) vs 18% (17/96) if utDNA+.
- utDNA+ correlated with noninvasive residual disease (<T2N0M0); ctDNA+ with invasive disease or N+/M+.
- 24-month EFS: dual-negative 90% (83-97), utDNA+ only 75% (65-87), dual-positive 55% (41-75).
Conference abstract, exploratory, 25% of ITT. Full paper not found in PubMed.
Peer-reviewed
utDNA and plasma ctDNA MRD (exploratory) plus clinical end points
Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results.
Necchi A, Guerrero-Ramos F, Crispen PL, Herrera-Imbroda B, Garje R, Szabados B, Peyton CC, Pradere B, Ku JH, Shore N, Bogemann M, Preston MA, Xylinas E, Sanchez de Llano C, Gong C, Hasan M, Urtishak K, Battaglia S, Stitou H, Bhanvadia S, Sweiti H, Psutka SP (22 authors on PubMed; Galsky MD is not on this list).
J Clin Oncol 2026;44(7):586-597. Published 3 December 2025.
n: 159 treated; 88 cohort 1 and 46 cohort 2 underwent RC; utDNA available 67 at baseline, 65 at week 12
Phase 2, cisplatin-ineligible or -refusing cT2-T4a N0M0 MIBC planned for RC; 5:3 randomization, cohort 1 TAR-200 + cetrelimab, cohort 2 cetrelimab alone. Data cutoff 9 May 2025.
Assay: utDNA and ctDNA MRD; vendor and gene content not named in the abstract (vendor and gene content are not named in the abstract).
- pCR, pOR (<=ypT1N0), 1-year RFS: 38%, 53%, 77% in cohort 1 vs 28%, 44%, 64% in cohort 2.
- Baseline utDNA+ 55/67 (82.1%); week 12 utDNA+ 34/65 (52.3%).
- Week-12 utDNA- and clearance correlated with pCR (P<10^-5 and P<10^-3 in abstract; Fisher P=5.4e-6 for week-12 status in results text).
- 22/27 (81.5%) who achieved pCR were utDNA- at week 12 vs 7/33 (21.2%) who did not. ROC 0.80 (0.70-0.90); NPV 0.81.
- Clearance in 14/30 (46.7%) with available data (7/18 C1, 7/12 C2). 12/15 (80.0%) baseline+ with pCR had clearance vs 2/15 (13.3%) without pCR.
- ctDNA- at baseline and week 12 associated with longer RFS (P=0.04 and 0.01).
- Authors: utDNA and ctDNA support further investigation as biomarkers for residual local and nonlocal disease, respectively.
Not on the PubMed author list of this JCO paper. Galsky's own utDNA work is the HCRN GU16-257 PNAS 2026 paper.
Peer-reviewed
clinical (utDNA not in main abstract)
TAR-200 for BCG-Unresponsive High-Risk NMIBC: Results From the Phase IIb SunRISe-1 Study.
Daneshmand S, Van der Heijden MS, Jacob JM, et al., including Necchi A.
J Clin Oncol 2025;43(33):3578-3588.
- The main paper’s abstract does not report utDNA. Complete numeric utDNA results from ESMO 2025 abstract 3088P were not extracted from the primary abstract, so those rates are not shown.
ESMO 2025 abstract 3088P (Ann Oncol, S0923-7534(25)04622-8) and a J&J Medical Connect congress PDF address molecular markers including baseline urinary tumor DNA MRD. Complete numeric utDNA results were not independently extracted from the primary abstract. Rates from that abstract are not included.
Peer-reviewed
clinical outcomes in FGFR3/2-altered NMIBC; utDNA/urine FGFR monitoring not in final abstract
Erdafitinib in Patients with High- and Intermediate-risk Non-muscle-invasive Bladder Cancer: Final Analysis of THOR-2 Study.
Daneshmand S, Zaucha R, Catto JWF, Tran B, Master V, Lotan Y, et al., including Maranchie JK.
Eur Urol 2026;89(2):165-173.
- Cohort 1 (HR papillary, prior BCG), n=73, 2:1 erdafitinib vs intravesical chemo: median RFS NR (28.6 mo-NE) vs 11.6 mo, HR 0.28 (0.13-0.61), nominal P=0.0007.
- Cohort 2 (CIS +/- papillary), n=16: CR 94% at 8 weeks, 81% at 32 weeks; mDoR 23.3 months.
- Cohort 3 (IR), n=18: CR 89%.
A urine FGFR or utDNA monitoring analysis is not described in the final-paper abstract. How FGFR3/2 alterations were ascertained (tissue vs urine) is not stated in that abstract.
Peer-reviewed
plasma tumor-informed ctDNA (NOT utDNA)
ctDNA-guided immunotherapy following radical cystectomy for muscle-invasive bladder cancer: results from the TOMBOLA trial.
Dyrskjot L, Birkenkamp-Demtroder K, Nordentoft I, et al., including Jensen JB.
Ann Oncol 2026;37(5):712-724.
n: 192 enrolled, 178 assessable, median FU 34 months
Danish multicenter, open-label, single-arm phase 2. MIBC after NAC and RC. ctDNA+ started atezolizumab up to 1 year; ctDNA- received IO only if imaging showed metastases.
Assay: Serial tumor-informed plasma ctDNA (not utDNA)
- 104 (58%) ctDNA+ within 2 years after RC, 63% of those within 4 months.
- Median lead time ctDNA to imaging-confirmed recurrence: 90 days (range -61 to 961).
- 60% (50/84) of ctDNA+ patients who completed atezo with scans/ctDNA for the primary end point achieved complete molecular and radiographic response.
- 1-year RFS 97% if ctDNA- vs 76% if ctDNA+.
Peer-reviewed
plasma ctDNA (NOT utDNA)
Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma.
Christensen E, Birkenkamp-Demtroder K, Sethi H, et al., including Dyrskjot L.
J Clin Oncol 2019;37(18):1547-1557.
n: 68 patients, 656 plasma samples
Assay: Tumor-informed ultra-deep sequencing (median 105,000x)
- ctDNA at diagnosis HR 29.1, P=0.001.
- After cystectomy, ctDNA identified metastatic relapse with 100% sensitivity and 98% specificity; median lead time 96 days.
- ctDNA dynamics during chemo associated with recurrence (P=0.023); pathologic downstaging was not.
Peer-reviewed
utDNA
Urine tumor DNA detection of minimal residual disease in muscle-invasive bladder cancer treated with curative-intent radical cystectomy: A cohort study.
Chauhan PS, Chen K, Babbra RK, et al., including Smith ZL, Arora VK, Chaudhuri AA.
PLoS Med 2021;18(8):e1003732.
n: 42 localized bladder cancer (32 MIBC, 19 of those with NAC) and 15 healthy adults
Urine on the day of curative-intent RC
Assay: uCAPP-Seq, tumor-naive (Diehn-group method; WashU / Chaudhuri lab, not a Diehn-lab paper)
- Median utDNA 0% healthy vs 2.4% patients; 4.3% if residual disease (n=16) vs 0% if pCR (n=26), P=0.002.
- utDNA MRD vs absence of pCR: sensitivity 81%, specificity 81%; LOO accuracy 81% (P=0.007).
- PFS HR 7.4 (1.4-38.9), P=0.02.
- Mutation concordance with tumor in 5 patients: 85%.
Peer-reviewed
utDNA multi-omics
Urine cell-free DNA multi-omics to detect MRD and predict survival in bladder cancer patients.
Chauhan PS, Shiang A, Alahi I, et al., including Chaudhuri AA.
NPJ Precis Oncol 2023;7(1):6.
n: 74
Localized bladder cancer
Assay: ULP-WGS plus uCAPP-Seq
- Random-forest LOOCV 87% sensitive for residual disease vs surgical pathology.
- PFS HR 3.00, P=0.01; OS HR 4.81, P=0.009.
- Urine metrics predicted pCR 'far better than plasma ctDNA was able to.'
Peer-reviewed
clinical bladder-sparing (context for utDNA follow-up)
Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.
Galsky MD, Daneshmand S, Izadmehr S, et al.
Nat Med 2023;29(11):2825-2834.
n: 76
- cCR 43% (33/76, 95% CI 32-55%); 32 of 33 with cCR opted to forgo immediate cystectomy; PPV of cCR 0.97 (0.91-1).
Peer-reviewed
plasma ctDNA and utDNA
Monitoring of plasma and urine tumor-derived DNA to inform bladder-sparing approaches for patients with muscle-invasive bladder cancer.
Galsky MD, Izadmehr S, Yu M, Curtis SD, Douville C, et al., including Bettegowda, Kinzler, Papadopoulos, Vogelstein, Wang Y.
Proc Natl Acad Sci USA 2026;123(8):e2533449123.
Exploratory liquid biopsy in the gem/cis/nivo bladder-sparing trial; tumor-informed academic assay; authors note relatively small sample.
Assay: Tumor-informed academic ctDNA and utDNA assay
- 3-year bladder-intact survival among cCR after four rounds of systemic therapy: 69%.
- Metastatic risk if pretreatment ctDNA detectable vs undetectable: HR 4.68 (1.10-43.35), P=0.036.
- Only 4.5% (1 of 22) with undetectable baseline ctDNA developed metastatic disease.
- utDNA more sensitive than plasma ctDNA for residual disease in the bladder.
- Detectable utDNA in patients with cCR associated with shorter bladder-intact survival, HR 6.47 (1.34-31.31), P=0.008.
first author — this is the Galsky utDNA study
Peer-reviewed
tissue/immune biomarkers; utDNA not in abstract
Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial.
Powles T, Kockx M, Rodriguez-Vida A, et al.
Nat Med 2019.
n: 95
- pCR 31% (95% CI 21-41%). Biomarkers are tissue and immune contexture; utDNA is not reported in the abstract.
Peer-reviewed
urine DNA (mutations + aneuploidy)
Non-invasive detection of urothelial cancer through the analysis of driver gene mutations and aneuploidy.
Springer SU, Chen CH, Rodriguez Pena MDC, et al., including Papadopoulos, Kinzler, Vogelstein, Netto.
eLife 2018;7:e32143.
n: 570 at risk for BC; 56 UTUC; surveillance subset
Assay: UroSEEK: 11 genes plus copy-number changes on 39 chromosome arms
- Positive in 83% of those who developed BC; combined with cytology, 95%.
- UTUC: 75% of 56 positive (79% of non-invasive tumors).
- Surveillance: genetic abnormalities in 68% of urines from patients with clinical recurrence.
- Low-grade BC: UroSEEK 67%, cytology 0%.
Peer-reviewed
urine DNA methylation
Urine DNA methylation assay enables early detection and recurrence monitoring for bladder cancer.
Chen X, Zhang J, Ruan W, et al.
J Clin Invest 2020;130(12):6278-6289. utMeMA.
n: Model built in 313; prospective multicenter validation 175
- 2-marker model: accuracy 86.7%, sensitivity 90.0%, specificity 83.1%.
- Early-stage Ta and low-grade: sensitivity 64.5% vs cytology 11.8% and FISH 15.8%.
Peer-reviewed
multitarget urine tumor DNA (mutations + methylation)
Clinical effectiveness of a multitarget urine DNA test for urothelial carcinoma detection: a double-blinded, multicenter, prospective trial.
Wu J, Lin Y, Yang K, et al.
Mol Cancer 2024;23(1):57. UI-Seek.
n: Development 382; prospective validation 947 (ChiCTR2300076543)
Assay: FGFR3 and TERT mutations plus ONECUT2 and VIM methylation
- Sensitivity 91.37%, specificity 95.09%.
- 75.81% for low-grade Ta; >93% for high-grade Ta and higher stages; >90% for both bladder and upper-tract tumors.
- Post-surgery UC-score decreased in 97.7% (43/44).
Peer-reviewed
utDNA methylation (BladMetrix)
Distinct longitudinal patterns of urine tumor DNA in patients undergoing surveillance for bladder cancer.
Vedeld HM, et al.
Mol Oncol 2024;18(11):2684-2695.
n: 47 patients, 2-year surveillance
- Detected 21/23 recurrences (91%): 5/5 T1, T2, and CIS (100%) and 10/12 Ta (83%); <1% false-negative tests.
- Authors estimate a potential 55% reduction in cystoscopies, benefiting 79% of patients (estimate from the paper, not a randomized result).
- 11/23 recurrences (48%) detected earlier with utDNA than cystoscopy.
- Residual-utDNA patterns interpreted as MRD in 6% and field effect in 15%.
Peer-reviewed
urinary tumor-derived DNA plus multi-omics
Elevated T-cell Exhaustion and Urinary Tumor DNA Levels Are Associated with BCG Failure in Patients with NMIBC.
Strandgaard T, Lindskrog SV, Nordentoft I, Christensen E, Birkenkamp-Demtroder K, et al., including Jensen JB, Dyrskjot L.
Eur Urol 2022;82(6):646-656.
n: 156 BCG-treated NMIBC; urine tdDNA n=187 samples
- Absence of post-BCG tdDNA clearance identified patients at high risk of recurrence (P=0.018).
- Post-BCG HG recurrence associated with T-cell exhaustion (P=0.002).
Peer-reviewed
utDNA (UroAmp)
Urine Tumor DNA to Stratify the Risk of Recurrence in Patients Treated with Atezolizumab for BCG-unresponsive NMIBC.
St-Laurent MP, Singh P, McConkey DJ, et al., including Lerner SP, Black PC.
Eur Urol 2025;88(5):430-434. SWOG S1605.
n: UroAmp at baseline n=89 and 3 months n=77
Assay: UroAmp
- CR at 6 months: 13% of UroAmp+ vs 71% of UroAmp- at baseline (P<0.001).
- 18-month EFS 23% vs 51% (HR 2.8, P<0.001).
- Among 51 with no clinical evidence of disease at 3 months: 18-month EFS 38% if UroAmp+ vs 86% if negative (HR 3.5, P=0.01).
Peer-reviewed
utDNA
Postinduction Urine Tumor DNA Is Predictive for Response to Maintenance Intravesical Therapy in NMIBC.
Lotan Y, Korman H, Gadzinski A, et al.
Eur Urol Oncol 2026. INSITE, observational.
n: 140 evaluable, 47% received maintenance
- utDNA-: no significant RFS benefit from maintenance (HR 1.35, 0.50-3.64, P=0.6); 24-month RFS 88% with or without maintenance.
- utDNA+: maintenance associated with better RFS (HR 0.22, 0.09-0.52, P<0.001); 24-month RFS 68% with maintenance vs 16% without.
- Observational; not a randomized test of utDNA-guided maintenance.
Bibliographic catalog
Additional verified 2025-2026 utDNA citations
- Bahlburg et al. J Urol 2026. utDNA in high-risk NMIBC receiving therapy.
- Huang et al. JCO Precis Oncol 2026. Post-resection urinary tumor DNA in NMIBC.
- Wu et al. MedComm 2026. Early detection and recurrence monitoring in NMIBC.
- Cancer Sci 2026. utDNA to identify candidates for repeat TURBT. n=161, residual tumor 35%; sensitivity 80.7%, specificity 96.2%, accuracy 90.7%.
- 2026 longitudinal UTUC utDNA paper.
- Li, Linscott, Murthy, Rose et al. medRxiv. Label as preprint, not a journal article.Preprint, not a journal article
GI, including colorectal
Level 1
- PositiveNot named in the abstractCirculating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer.
Tie J, et al. The New England Journal of Medicine. 2022. PMID 35657320. doi 10.1056/NEJMoa2200075
A randomized trial tested whether a ctDNA-guided approach could reduce adjuvant chemotherapy in stage II colon cancer without increasing recurrence. The abstract does not name the assay.
- NegativeNot named in the abstractCirculating tumor DNA-guided adjuvant therapy in locally advanced colon cancer: the randomized phase 2/3 DYNAMIC-III trial.
Tie J, et al. Nature Medicine. 2025. PMID 41115959. doi 10.1038/s41591-025-04030-w
In 968 people with stage III colon cancer, ctDNA-guided de-escalation did not meet non-inferiority and escalation did not improve recurrence-free survival, although ctDNA-negative disease had a much lower recurrence risk.
- NegativeNot named in the abstractPost-adjuvant chemotherapy in ctDNA-positive patients with resected colorectal cancer: a randomized phase 3 trial.
Bando H, et al. Nature Medicine. 2026. PMID 42260101. doi 10.1038/s41591-026-04428-0
ALTAIR (NCT04457297) randomized 243 ctDNA-positive people without radiographic disease to trifluridine/tipiracil or placebo. Median disease-free survival was 9.30 versus 5.55 months (HR 0.79, P = 0.107). The primary endpoint was not met.
- NegativeNot named in the abstractCirculating tumor DNA-guided de-escalation or escalation of adjuvant therapy in high-risk stage II and stage III colon cancer: the phase 2 PEGASUS trial.
Marsoni S, et al. Nature Cancer. 2026. PMID 42736431. doi 10.1038/s43018-026-01237-9
Of 135 people, 26% were ctDNA-positive after surgery. The primary endpoint in ctDNA-negative people was not met (2-year relapse-free rate 88%, below the 92% threshold).
Conference data
- Level 1negativeASCO Annual Meeting 2025
ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG).
Tie, Jeanne · Abstract 3503 · DYNAMIC-III · 961 eligible randomized; 259 (27%) ctDNA-positive (this analysis). 115/129 in the ctDNA-informed arm received escalation (65 FOLFOXIRI).
tumor-informed (commercial name not stated in this abstract)
2-year RFS with ctDNA-informed escalation was 52% vs 61% with standard of care (HR 1.11, 90% CI 0.83-1.48; P=0.6). 3-year RFS was similar for FOLFOXIRI vs FOLFOX/CAPOX (47% vs 51%; HR 1.09, P=0.7). Recurrence risk increased with ctDNA burden (3-year RFS 78%, 63%, 36%, and 22% across MTM/mL quartiles; P<0.01). Escalation, including to FOLFOXIRI, did not improve RFS.
- Level 1negativeASCO Gastrointestinal Cancers Symposium 2025
A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): The ALTAIR study.
Bando, Hideaki · Abstract LBA22 · LBA · ALTAIR (CIRCULATE-Japan) · 243 randomized (122 FTD/TPI, 121 placebo); 96.3% had received standard-of-care postoperative therapy
Signatera (Natera), personalized tumor-informed
Median DFS was 9.30 vs 5.55 months (HR 0.79, 95% CI 0.60-1.05; P=0.107); the primary endpoint was not met. The abstract reports a more pronounced benefit in resected oligometastatic stage IV disease and a trend toward greater DFS benefit at higher baseline MTM/mL. Grade >=3 adverse events occurred in 73.0% vs 3.3%. OS data were immature (24 events).
- Level 1mixedESMO Congress 2025
LBA9 ctDNA-guided adjuvant chemotherapy de-escalation in stage III colon cancer: Primary analysis of the ctDNA-negative cohort from the randomized AGITG DYNAMIC-III trial (Intergroup study of AGITG and CCTG)
Tie, J. · Abstract LBA9 · LBA · DYNAMIC-III · 702 ctDNA-negative of 968 evaluable (72.5%); 353 ctDNA-guided, 349 standard; median follow-up 45 months
tumor-informed (testing 5-6 weeks post-surgery; commercial name not stated in the abstract)
Protocol de-escalation occurred in 90.4%. Oxaliplatin-based chemotherapy use fell (34.8% vs 88.6%, P<0.001), as did grade 3+ adverse events of special interest (6.2% vs 10.6%, P=0.037) and treatment-related hospitalization (8.5% vs 13.2%, P=0.048). Non-inferiority of 3-year RFS was not confirmed (85.3% vs 88.1%; difference -2.8%; 97.5% lower CI -8.0%; NI margin 7.5%). A pre-planned subgroup of clinically low-risk T1-3N1 tumors had difference -2.2% (97.5% lower CI -7.2%), within the NI margin.
Full paperSlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.
- Level 1mixedESMO Congress 2025
723O Post-surgical liquid biopsy-guided treatment of stage III and high-risk stage II colon cancer patients: Final results of the PEGASUS trial
Marsoni, S. · Abstract 723O · oral · PEGASUS · 135 patients (100 liquid-biopsy-negative, 35 positive); median follow-up 33.5 months
Guardant Reveal (v L1.2)
Among patients with two consecutive post-surgical negative tests, 12 relapses occurred, for a 2-year no-evidence-of-disease rate of 88% (90% CI 81-93). The predefined feasibility threshold (fewer than 14 relapses among 134 negative patients to exclude 85% in favor of 92%) was not met, though the point estimate exceeded 85%. In the 35 positive patients, 13 (37%) relapsed; 2-year time-to-relapse was 87.6% vs 61.5% (HR 3.22, P=0.0013).
SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.
- Level 1negativeESMO Gastrointestinal Cancers Congress 2025
3O Association of ctDNA clearance with disease-free survival, safety, and quality of life from ctDNA-directed therapy: Findings from the ALTAIR study
Kotaka, M. · Abstract 3O · oral · ALTAIR (CIRCULATE-Japan) · n=243
Signatera (Natera)
ctDNA clearance at treatment completion was 17.2% with FTD/TPI vs 12.4% with placebo (P=0.367), a non-significant difference. Grade >=3 neutropenia occurred in 56.6% on FTD/TPI; 37.7% required dose reduction. Global health status declined at week 8 on FTD/TPI (P=0.028) but arms did not differ from week 24 onward. DFS results match the ASCO GI primary report (HR 0.79, P=0.107).
- Level 1positiveESMO Gastrointestinal Cancers Congress 2025
LBA1 Dynamic circulating tumor DNA methylation monitoring guiding postoperative surveillance in non-metastatic colorectal cancer: Interim analysis of FIND trial
Peng, J. · Abstract LBA1 · LBA · FIND · 728 randomized (363 ctDNA-guided, 365 standard); interim, median follow-up 12 months
single-tube methylation-specific quantitative PCR (mqMSP) targeting 10 methylation markers (stated detection to 0.01% allelic fraction)
Cumulative recurrence rates did not differ (P=0.671 ITT). ctDNA-guided surveillance increased the proportion of recurrent patients who received curative-intent therapy (50.0% vs 22.6%; relative risk 2.214, 95% CI 1.060-4.780; P=0.034), the trial's primary endpoint. This is an interim analysis.
- Level 1prognosticASCO Annual Meeting 2024
The potential role of serial circulating tumor DNA (ctDNA) testing after upfront surgery to guide adjuvant chemotherapy for early stage pancreatic cancer: The AGITG DYNAMIC-Pancreas trial.
Lee, Belinda · Abstract 107 · DYNAMIC-Pancreas (AGITG) · 102 enrolled; 40 ctDNA-positive, 54 negative, 4 ineligible (no tumor mutation); median follow-up 36 months
tumor-informed (brand not named in the extracted results)
A tumor-informed approach was feasible (first draw at a median of 5 weeks). 40% were ctDNA-positive after resection, independent of usual clinicopathologic risk factors. Of 54 ctDNA-negative patients, 24 (44%) were de-escalated to a planned 3 months of adjuvant chemotherapy. Median RFS was 13 months if ctDNA-positive vs 22 months if negative (HR 0.52, P=0.003).
- Level 1positiveASCO Annual Meeting 2024
Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: Overall survival and updated 5-year results from the randomized DYNAMIC trial.
Tie, Jeanne · Abstract 108 · DYNAMIC · same randomized cohort; median follow-up 59.6 months
tumor-informed Safe-SeqS (as in the primary DYNAMIC report)
5-year RFS was 88% vs 87% (difference 1.1%, 95% CI -5.8% to 8.0%). 5-year OS was 93.8% vs 93.3% (HR 1.05, 95% CI 0.47-2.37; P=0.887). In treated ctDNA-positive patients, end-of-treatment clearance occurred in 35/40 (87.5%); 5-year RFS was 85.2% with clearance vs 20.0% with persistence (HR 15.4, P<0.001). Higher post-surgery mutant tumor molecules (>=0.38 MTM/mL) were associated with lower clearance and worse RFS.
- Level 1mixedASCO Gastrointestinal Cancers Symposium 2024
Circulating tumor DNA analysis informing adjuvant chemotherapy in locally advanced rectal cancer: The randomized AGITG DYNAMIC-Rectal study.
Tie, Jeanne · Abstract 12 · DYNAMIC-Rectal · 230 eligible (155 ctDNA-guided, 75 standard); recruitment stopped early because of COVID-19 and uptake of total neoadjuvant therapy
tumor-informed (same program as DYNAMIC; commercial name not re-stated in the extracted results)
In the ctDNA-guided arm, 42/150 (28%) with successful testing were ctDNA-positive. Adjuvant chemotherapy was used in 46% vs 77% (P<0.001). 3-year RFS was 76% vs 82% (difference 6%, 95% CI -6% to 17%). The abstract states the sample size precludes conclusions about non-inferiority. Recurrence in untreated ctDNA-negative patients was often lung-only (12/15, 80%).
- Level 1negativeASCO Gastrointestinal Cancers Symposium 2024
Phase II results of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) phase II/III study.
Morris, Van K. · Abstract 5 · NRG-GI005 (COBRA) · 635 randomized (318 observation, 317 ctDNA-directed); phase II clearance analysis used the first 16 patients with baseline ctDNA detected
Guardant LUNAR (mutations plus colon cancer-specific methylation)
Clearance of ctDNA at 6 months was observed in 3/7 (43%) in the observation arm and 1/9 (11%) in the chemotherapy arm (P=0.98). The phase II endpoint was not met; enrollment was halted under prespecified stopping rules based on the original assay. No improvement in clearance was seen after 6 months of chemotherapy in ctDNA-detected resected stage IIA colon cancer. The abstract notes future integral-biomarker trials must account for assay specificity in this population.
- Level 1mixedESMO Congress 2023
LBA28 The PEGASUS trial: Post-surgical liquid biopsy-guided treatment of stage III and high-risk stage II colon cancer patients
Lonardi, S. · Abstract LBA28 · LBA · PEGASUS · 135 patients; median follow-up 20.8 months at this report
Guardant Reveal (v L1.2)
Post-surgery ctDNA was detected in 35/135 (26%). Relapse occurred in 12/35 (34%) ctDNA-positive vs 9/100 (9%) ctDNA-negative patients (HR 4.37, P=0.0003); the 9 negative relapses were the prespecified false-negative count. After 3 months of CAPOX, 11/35 positive patients converted to negative, but 8/11 later relapsed or re-positivized. Of 23 who received FOLFIRI after CAPOX, 11 converted and were relapse-free at analysis.
SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.
- Level 1positiveASCO Annual Meeting 2022
Adjuvant chemotherapy guided by circulating tumor DNA analysis in stage II colon cancer: The randomized DYNAMIC trial.
Tie, Jeanne · Abstract LBA100 · LBA · DYNAMIC · 455 randomized (302 ctDNA-guided, 153 standard management)
tumor-informed Safe-SeqS (named in the abstract)
Fewer patients in the ctDNA-guided arm received adjuvant chemotherapy (15.3% vs 27.9%; odds ratio 2.14; P=0.002). ctDNA-guided management was non-inferior for 2-year RFS (93.5% vs 92.4%; difference 1.1%, 95% CI -4.1% to 6.2%). After chemotherapy, 3-year RFS in ctDNA-positive patients was 86.4%; without chemotherapy, 3-year RFS in ctDNA-negative patients was 92.5% (96.7% in clinically low-risk disease).
Level 2
- Neutral or mixedSignateraPredictive Role of Circulating Tumor DNA in Stage III Colon Cancer Treated With Celecoxib: A Post Hoc Analysis of the CALGB (Alliance)/SWOG 80702 Phase 3 Randomized Clinical Trial.
Zhang GQ, et al. JAMA Oncology. 2026. PMID 41343176. doi 10.1001/jamaoncol.2025.5144
A post hoc analysis of CALGB/SWOG 80702 examined whether postoperative ctDNA, measured with Signatera, predicted survival with adjuvant celecoxib plus chemotherapy in stage III colon cancer.
- PositiveNot named in the abstractMolecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer.
Kotani D, et al. Nature Medicine. 2023. PMID 36646802. doi 10.1038/s41591-022-02115-4
GALAXY, an observational arm of CIRCULATE-Japan, measured ctDNA before and after surgery in 1,039 people with stage II-IV resectable colorectal cancer and related it to adjuvant chemotherapy. The abstract excerpt does not name the assay.
- Neutral or mixedNot named in the abstractA Tumor-Naïve ctDNA Assay Detects Minimal Residual Disease in Resected Stage II or III Colorectal Cancer and Predicts Recurrence: Subset Analysis from the GALAXY Study in CIRCULATE-Japan.
Nakamura Y, et al. Clinical Cancer Research. 2025. PMID 39513962. doi 10.1158/1078-0432.CCR-24-2396
A tumor-naive plasma-only assay was used to call molecular residual disease in 80 people with stage II or III colorectal cancer selected from the GALAXY study. The abstract does not name the product.
- Neutral or mixedmPCR-NGSSurvival benefit of adjuvant chemotherapy based on molecular residual disease detection in resected colorectal liver metastases: subgroup analysis from CIRCULATE-Japan GALAXY.
Kataoka K, et al. Annals of Oncology. 2024. PMID 39293512. doi 10.1016/j.annonc.2024.08.2240
In people with colorectal liver metastases from GALAXY, ctDNA was measured with a personalized tumor-informed 16-plex PCR sequencing assay and examined against the survival association of adjuvant chemotherapy.
- PositiveLatitudeValidation of a methylation-based, tissue-free MRD assay in colorectal cancer patients from the GALAXY study.
Nakamura Y, et al. NPJ Precision Oncology. 2026. PMID 41555007. doi 10.1038/s41698-026-01277-5
The methylation-based tissue-free Latitude assay was tested on 1,230 time points from 195 people in GALAXY, and ctDNA positivity was associated with worse disease-free survival in both the residual-disease and surveillance windows.
- Neutral or mixedNot named in the abstractResidual circulating tumor DNA after adjuvant chemotherapy effectively predicts recurrence of stage II-III gastric cancer.
Yuan SQ, et al. Cancer Communications. 2023. PMID 37837629. doi 10.1002/cac2.12494
A prospective cohort of 100 people with stage II or III resectable gastric cancer collected tumor and perioperative plasma to test whether ctDNA after adjuvant chemotherapy predicted recurrence. The abstract does not name the assay.
- PositivemPCR-NGSCirculating Tumor DNA in Stage III Colorectal Cancer, beyond Minimal Residual Disease Detection, toward Assessment of Adjuvant Therapy Efficacy and Clinical Behavior.
Henriksen TV, et al. Clinical Cancer Research. 2022. PMID 34625408. doi 10.1158/1078-0432.CCR-21-2404
In 168 people with stage III colorectal cancer, postoperative ctDNA detection predicted recurrence (HR 7.0). Sixteen patient-specific variants were sequenced.
- PositiveGuardant RevealRisk stratification by circulating tumor DNA-based pretreatment genomic profile and post-operative molecular residual disease detection in resectable colorectal oligometastases: PRECISION, a prospective multicenter study
Kobayashi S, Takamoto T, Shiomi A, Takahashi A, Shiozawa M, Taniguchi H, Nishizawa Y, Nobuoka D, Yasuta S, Kato T, Ando K, Taketomi A, Takahashi Y, Natsume S, Kojima T, Nakamura T, Mitani R, Wakabayashi M, Yoshino T, Nakamura Y, et al. ESMO Open. 2026. PMID 42950585. doi 10.1016/j.esmoop.2026.108622
In the prospective PRECISION study of 118 eligible patients with resectable colorectal oligometastases, pretreatment Guardant360 genomic profiling and postoperative Guardant Reveal MRD were each independently associated with shorter recurrence-free survival (multivariable HRs 3.28 and 4.07); patients with both a poor genomic profile and postoperative MRD had the highest recurrence risk (RFS HR 13.28), and those with an optimal profile and undetected MRD had a 2-year RFS of 77.8%.
- PositiveNot named in the abstractPostoperative Tumor-Informed Circulating Tumor DNA Status for Molecular Residual Disease Detection After Curative-Intent Resection of Pancreatic Ductal Adenocarcinoma: A Systematic Review and Meta-Analysis
Mirza W, Rafi M, Siddiqui Z, Mehboob M, Khan MZ, Khan K, Ishaq MH, Shalikh M, Altabawi M, Imtiaz A, Ali RN. Journal of Gastrointestinal Cancer. 2026. PMID 43013192. doi 10.1007/s12029-026-01629-1
A systematic review and meta-analysis of five observational cohorts (237 patients) found that postoperative tumor-informed ctDNA positivity after curative-intent PDAC resection was associated with higher radiological recurrence (RR 2.50, 95% CI 1.90-3.28) and shorter disease-free and overall survival (HRs 8.11 and 5.15); the authors caution that a negative result did not reliably exclude residual disease.
Conference data
- Level 2ESMO Gastrointestinal Cancers Congress 2026
ctDNA status and adjuvant chemotherapy after resection of colorectal liver metastases: An overall survival analysis of the GALAXY study
Kozo Kataoka · Abstract 8O · Proffered Paper (oral) · GALAXY
SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.
- Level 2prognosticASCO Gastrointestinal Cancers Symposium 2025
Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort.
Shah, Purvi K. · Abstract 15 · BESPOKE CRC · 1,001 in the sub-cohort; 625 (62.4%) received ACT; MRD-window results in 420 stage II and 505 stage III
Signatera (tumor-informed)
MRD-window ctDNA positivity was 8.1% (34/420) in stage II and 24.9% (126/505) in stage III, with DFS HR 10.4 and 10.1, respectively (both P<0.0001). Combined 24-month DFS was 91.7% if MRD-negative vs 41.4% if MRD-positive. During surveillance, conversion to ctDNA-positive was associated with markedly worse DFS in both observation and ACT-treated patients (stage II observation HR 34.9; stage III ACT HR 54.6).
- Level 2prognosticASCO Gastrointestinal Cancers Symposium 2024
Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study.
Kasi, Pashtoon Murtaza · Abstract 9 · BESPOKE CRC · 154 stage II and 196 stage III in this interim subset; MRD results in 295; median follow-up 24.8 months
Signatera (tumor-informed)
MRD positivity was 15.6% (46/295; 6.9% stage II, 22.4% stage III) and was associated with inferior DFS (HR 20.8, 95% CI 10.0-43.4). Within the MRD-positive group, patients who received ACT had longer DFS than those observed (median 18.7 vs 6.7 months; HR 3.9, P=0.01). No ACT benefit was observed in MRD-negative patients (HR 1.1, P=0.89). Treatment was not randomized.
- Level 2prognosticASCO Gastrointestinal Cancers Symposium 2024
Circulating tumor DNA (ctDNA) dynamics in patients with colorectal cancer (CRC) with molecular residual disease: Updated analysis from GALAXY study in the CIRCULATE-JAPAN.
Yukami, Hiroki · Abstract 6 · GALAXY (CIRCULATE-Japan) · 2,518 analyzed of 3,034 enrolled; MRD-window results in 2,093 (309 [14.8%] positive)
Signatera (tumor-informed)
MRD-positive patients had inferior DFS (HR 15.75, 95% CI 12.59-19.68, P<0.0001). Those who remained positive 3 months after MRD detection were more than 5 times as likely to recur as those with clearance (HR 5.4, P<0.0001). Of 181 MRD-positive patients who received adjuvant therapy, 72.9% had clearance; 54% of those with later samples had sustained clearance, which was associated with far better outcomes than transient clearance (HR 32.57). A 50% or greater drop in MTM/mL at 6 months among treated MRD-positive patients was associated with better DFS (HR 2.39, P=0.004).
- Level 2ESMO Congress 2024
Association of ctDNA-based MRD detection and MRD clearance with short-term overall survival in resectable colorectal cancer: Updated analysis of CIRCULATE-Japan GALAXY
Jun Nagata · Abstract 553P · Poster · CIRCULATE-Japan GALAXY
PosterPoster PDF. An ASCO or ESMO member login may be required.
- Level 2ESMO Congress 2024
Association between copy number aberration and ctDNA MRD in colorectal cancer: CIRCULATE-Japan GALAXY
Tomoya Harima · Abstract 555P · Poster · CIRCULATE-Japan GALAXY
PosterPoster PDF. An ASCO or ESMO member login may be required.
- Level 2ESMO Congress 2024
Survival benefit of adjuvant chemotherapy based on MRD detection in resected colorectal liver metastases: Subgroup analysis from CIRCULATE-Japan GALAXY
Kozo Kataoka · Abstract 558P · Poster · CIRCULATE-Japan GALAXY
PosterPoster PDF. An ASCO or ESMO member login may be required.
- Level 2prognosticASCO Annual Meeting 2023
Circulating tumor DNA dynamics as an early predictor of recurrence in patients with radically resected colorectal cancer: Updated results from GALAXY study in the CIRCULATE-Japan.
Oki, Eiji · Abstract 3521 · GALAXY (CIRCULATE-Japan) · 2,083 analyzed of 3,615 enrolled; median follow-up 16.3 months
Signatera (tumor-informed)
286/2,083 (14%) were ctDNA-positive at the 4-week MRD timepoint and had inferior DFS (HR 12, 95% CI 9.1-15; P<0.0001). Versus patients who stayed negative (n=1,529), conversion from negative to positive (n=112) had HR 14.5 and persistent positivity (n=124) had HR 25.4. Median lead time from ctDNA to radiographic recurrence was 142 days among protocol-imaged recurrences.
- Level 2prognosticASCO Gastrointestinal Cancers Symposium 2022
Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan.
Kotaka, Masahito · Abstract 9 · GALAXY (CIRCULATE-Japan) · 1,365 patients enrolled June 2020-April 2021 (this analysis); median follow-up 6.6 months
Signatera (tumor-informed)
6-month DFS by 4-to-12-week ctDNA dynamics: 98% if negative-to-negative (n=618), 100% if positive-to-negative (n=58), 59% if negative-to-positive (n=32), and 45% if positive-to-positive (n=78); HR 52.3 comparing conversion to clearance vs persistent positivity (P<0.001). Among 4-week MRD-positive patients, 12-week clearance was 57% (54/95) with adjuvant chemotherapy vs 8% (7/93) without (P<0.001). 6-month DFS in 4-week MRD-positive patients was 84% vs 34% with vs without ACT (HR 0.15, P<0.001).
- Level 2ESMO Congress 2022
Tumour-naïve ctDNA analysis in resected colorectal cancer in the phase III ASCOLT trial
Daphne Day · Abstract 380P · Poster · ASCOLT
PosterPoster PDF. An ASCO or ESMO member login may be required.
- Level 2positiveASCO Annual Meeting 2021
Phase II study of anti-EGFR rechallenge therapy with panitumumab driven by circulating tumor DNA molecular selection in metastatic colorectal cancer: The CHRONOS trial.
Sartore-Bianchi, Andrea · Abstract 3506 · CHRONOS · 52 screened by liquid biopsy; 36 (69%) negative for RAS/BRAF/EGFR mutations; 27 enrolled and treated
ctDNA genotyping for RAS/BRAF/EGFR mutations (assay brand not named in the extracted results)
The primary endpoint was met: partial response in 8/27 (ORR 30%, 95% CI 12-47%). Disease control (PR plus SD lasting more than 4 months) was 59%. Median PFS was 16 weeks. This is metastatic anti-EGFR rechallenge guided by ctDNA resistance mutations, not adjuvant MRD.
Level 3
- PositiveGuardant RevealCirculating tumor DNA using a plasma-only assay predicts survival in patients with oligometastatic colorectal cancer after definitive therapy.
Sanz-Garcia E, et al. Journal of Gastrointestinal Oncology. 2025. PMID 40386606. doi 10.21037/jgo-24-819
A single-center prospective study used Guardant Reveal to test whether ctDNA after definitive therapy for oligometastatic colorectal cancer was associated with outcome.
- Neutral or mixedNeXT PersonalMonitoring treatment response using an ultra-sensitive ctDNA assay in advanced esophagogastric cancer patients.
Nixon AB, et al. Scientific Reports. 2026. PMID 41872254. doi 10.1038/s41598-026-43178-4
NeXT Personal was applied to 24 people with metastatic esophagogastric cancer in the phase 2 KeyLargo study, and every patient was ctDNA-positive at baseline.
- Neutral or mixedNot named in the abstractCirculating tumor DNA predicts recurrence and survival in patients with resectable gastric and gastroesophageal junction cancer.
Iden CR, et al. Gastric Cancer. 2025. PMID 39369091. doi 10.1007/s10120-024-01556-9
ctDNA was studied as a recurrence-risk marker in people with resectable gastric and gastroesophageal junction adenocarcinoma receiving perioperative chemotherapy. The abstract does not name the assay.
- Neutral or mixedNot named in the abstractCirculating Tumor DNA and Tissue Testing for Pancreatobiliary Tumors.
Mahadevia H, et al. JAMA Network Open. 2025. PMID 40938601. doi 10.1001/jamanetworkopen.2025.31373
The study compared mutation concordance between circulating tumor DNA and tissue next-generation sequencing in advanced pancreatobiliary tumors. The abstract does not name a commercial ctDNA assay.
- PositiveNot named in the abstractPerioperative Circulating Tumor DNA Dynamics in Patients Undergoing Cytoreductive Surgery for Colorectal Peritoneal Metastases
Brown KGM, Neilson T, Delisle M, Morgan RB, Maman Y, DiPeri T, Kearse L, You YN, Bednarski B, Konishi T, Behman R, Moon J, Messick C, Guraieb-Trueba M, Rodriguez-Bigas M, Chang GJ, Smith JJ, Song Y, Helmink B, Mansfield P, Fournier K, Willis J, Hu I, Dasari AN, Marincola Smith P, White MG. Annals of Surgical Oncology. 2026. PMID 43009710. doi 10.1245/s10434-026-20869-w
In a single-center series of 87 patients undergoing cytoreductive surgery for colorectal peritoneal metastases, postoperative ctDNA was detectable in 30 of 83 (36%) and was associated with shorter recurrence-free survival (HR 3.5), peritoneal recurrence-free survival (HR 3.1), and overall survival (HR 6.7); the abstract does not name the assay, and the paper is about peritoneal, not liver, metastases.
Conference data
- Level 3ESMO Congress 2026
Novel error-corrected tumor-informed whole-genome sequencing ctDNA analysis improves postoperative MRD detection in stage II-III colorectal cancer
Maria Honholt Jorgensen · Abstract 4273P · Poster
PosterPoster PDF. An ASCO or ESMO member login may be required.
- Level 3ESMO Congress 2026
Postoperative TAV16 ctDNA detects molecular residual disease and predicts relapse after pancreatic cancer resection
Miguel García Bartolomé · Abstract 3192eP · ePoster
PosterPoster PDF. An ASCO or ESMO member login may be required.
- Level 3ESMO Congress 2026
MUTE-Seq enables efficient single-digit-ppm tumor-informed ctDNA MRD monitoring in colorectal cancer
Junseok W Hur · Abstract 2446P · Poster
PosterPoster PDF. An ASCO or ESMO member login may be required.
- Level 3ESMO Congress 2022
A tumor-informed, hybrid-capture ctDNA assay for MRD detection in colorectal cancer after curative surgery
Sae-Won Han · Abstract 381P · Poster
PosterPoster PDF. An ASCO or ESMO member login may be required.