French testing of blood-based ctDNA to find leftover cancer after surgery in Stage III colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.