French testing of blood-based ctDNA to find leftover cancer after surgery in Stage III colorectal cancer
French Assessment of Minimal Residual Disease by Liquid Biopsies in Stage III Colorectal Patients
We will test whether blood-based ctDNA can find leftover cancer after surgery in people with Stage III colorectal cancer to help guide additional treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Montpellier, Hérault) |
| Trial ID | NCT06287814 on ClinicalTrials.gov |
What this trial studies
FRENCH.MRD.CRC is an observational arm of the GUIDE.MRD consortium that prospectively collects blood (liquid biopsy) samples from patients around the time of surgery, during chemotherapy, and in follow-up to look for circulating tumor DNA (ctDNA). Multiple commercial and academic ctDNA assays will be run on the same clinical samples to benchmark their technical performance and compare results to clinical outcomes. The protocol enrolls adults undergoing curative-intent resection for colorectal cancer at CHU de Montpellier, with longitudinal sample collection but no experimental therapy assigned by the study. Results will be used to identify the most reliable ctDNA tests and relevant time points for detecting minimal residual disease and early relapse.
Who should consider this trial
Good fit: Adults (≥18) with colorectal cancer who underwent curative-intent resection and specifically patients with UICC stage III disease who can give informed consent and attend follow-up visits are the intended participants.
Not a fit: Patients with verified distant metastases, hereditary colorectal cancer syndromes, malignant polyps post-polypectomy, those unable to comply with follow-up, pregnant or uninsured individuals are excluded and unlikely to benefit from this observational sample-banking effort.
Why it matters
Potential benefit: If successful, this work could help identify who truly needs more treatment after surgery and detect recurrence earlier, potentially sparing some patients unnecessary chemotherapy and allowing earlier intervention for others.
How similar studies have performed: Previous studies have shown that ctDNA can predict relapse after colorectal cancer surgery and guide adjuvant decisions in some settings, but head-to-head benchmarking of many ctDNA tests across standard time points remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
FRENCH.MRD.CRC PART I Inclusion criteria * Colon or rectal cancer, clinical tumor stage I-III. * Patient 18 years or older. * Scheduled for curative intent resection surgery (including "compromised" curative resections). Exclusion criteria * Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome. * Verified distant metastases. * Malignant colorectal polyps diagnosed after polypectomy. * Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study. * Pregnant or nursing woman, or in childbearing age and not willing to use contraception * Protected and vulnerable adult * Not covered by Health insurance * Patient unable to understand and sign written informed consent. FRENCH.MRD.CRC PART II Inclusion criteria * Participation in FRENCH.MRD.CRC part 1 - SURGERY * Colorectal cancer, UICC stage III * Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime) Exclusion criteria * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) related colon cancer * Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included) * Treated with neoadjuvant chemo-radiation therapy * Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma) * Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening * Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
Where this trial is running
Montpellier, Hérault
- CHU de Montpellier — Montpellier, Hérault, France (Recruiting)
Study contacts
- Principal investigator: Thomas BARDOL, M.D. — University Hospital, Montpellier
- Study coordinator: Catherine ALIX-PANABIERES, PhD
- Email: c-panabieres@chu-montpellier.fr
- Phone: +33411759931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.