Actively Recruiting
French Assessment of Minimal Residual Disease by Liquid Biopsies in Stage III Colorectal Cancer Patients
Led by University Hospital, Montpellier · Updated on 2025-07-10
70
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying stage III colorectal cancer to improve personalized treatment decisions using new diagnostic technologies. This research evaluates circulating tumor DNA (ctDNA) found in blood samples to better identify patients who need additional treatment after surgery. The study is part of the French contribution to the European GUIDE.MRD project, which aims to establish reliable ctDNA tests and their clinical usefulness in managing colorectal cancer. Participants provide blood samples at different times: before and after surgery, after adjuvant chemotherapy, and during routine surveillance. The study is divided into two parts: part 1 focuses on surgery, and part 2 follows patients during and after chemotherapy. Researchers will compare multiple ctDNA diagnostic tests to find the most accurate method for detecting residual disease and predicting relapse. Patients are followed for three years after surgery, with regular blood sample collections and clinical assessments. The study measures outcomes such as 3-year disease-free survival, time to cancer recurrence, overall survival, and how well ctDNA tests predict relapse compared to standard imaging. Data collected will also help create a unique collection of plasma and tissue samples for future research.
CONDITIONS
Brief Title
French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Colon or rectal cancer, clinical tumor stage I-III
- Patient 18 years or older
- Scheduled for curative intent resection surgery (including "compromised" curative resections)
- Participation in FRENCH.MRD.CRC part 1 - SURGERY (for part II)
- Colorectal cancer, UICC stage III (for part II)
- Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime) (for part II)
You will not qualify if you...
- Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
- Verified distant metastases
- Malignant colorectal polyps diagnosed after polypectomy
- Patients unlikely to comply with the protocol or unable to return for visits
- Pregnant or nursing women, or in childbearing age and not willing to use contraception
- Protected and vulnerable adults
- Not covered by health insurance
- Unable to understand and sign informed consent
- Inflammatory bowel disease related colon cancer (Crohn's disease or ulcerative colitis) (for part II)
- Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included) (for part II)
- Treated with neoadjuvant chemo-radiation therapy (for part II)
- Synchronous colorectal and non-colorectal cancer diagnosed per operative (except some skin cancers) (for part II)
- Other cancers within 3 years from eligibility screening (excluding colorectal or certain skin cancers) (for part II)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants undergo intended curative surgery for colorectal cancer with blood samples collected before and after surgery to assess minimal residual disease using ctDNA analysis.
1 visit before surgery and 1 visit after surgery
Duration - 3 to 6 months
Participants receive standard-of-care adjuvant chemotherapy for 3 or 6 months with blood samples collected immediately after chemotherapy to evaluate treatment response using ctDNA analysis.
Visits as part of routine chemotherapy care with 1 blood sample collection visit immediately after chemotherapy
Duration - Up to 3 years after surgery
Participants are monitored during standard-of-care follow-up with periodic blood sample collections and CT scans to detect early recurrence using ctDNA analysis alongside radiological imaging.
Periodic visits coinciding with routine CT scans during follow-up
Trial Site Locations
Total: 1 location
1
CHU de Montpellier
Montpellier, Hérault, France, 34295
Actively Recruiting
Research Team
C
Catherine ALIX-PANABIERES, PhD
T
Thomas BARDOL, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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