French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC)

NCT06287814 | Recruiting

• 1 other identifier: RECHMPL23_0299
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough. There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points. The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient. FRENCH-MRD-CRC is the French study of the european GUIDE.MRD project.

Conditions

Colorectal Cancer; Stage III Colon Cancer; Minimal Residual Disease; Liquid Biopsy

Keywords

Stage III colorectal cancer; Minimal Residual Disease; Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival (DFS)

  Disease-free survival was defined as the time between the date of the baseline blood sampling/inclusion\] and the date of the first event among or recurrence or death from any cause.

  3 years after end of recruitment

Secondary Outcomes (8)

• Sensitivity (Se) of the ctDNA diagnostics

  3 years after end of recruitment

• Specificity (Sp) of the ctDNA diagnostics

  3 years after end of recruitment

• Positive predictive value of the ctDNA diagnostics

  3 years after end of recruitment

• Negative predictive value of the ctDNA diagnostics

  3 years after end of recruitment

• Area under the curve of the ctDNA diagnostics

  3 years after end of recruitment

Study Arms (1)

Stage III colorectal cancer patients

MRD assessment by ctDNA analysis Patients will be managed according to current standard-of-care

Biological: Blood sample/lliquid biopsy

Interventions

Blood sample/lliquid biopsy BIOLOGICAL

ctDNA analysis

Stage III colorectal cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PART All patients with resected stage I to III CRC PART II Patients with stage III CRC with adjuvant chemotherapy

You may qualify if:

• Colon or rectal cancer, clinical tumor stage I-III.
• Patient 18 years or older.
• Scheduled for curative intent resection surgery (including "compromised" curative resections).

You may not qualify if:

• 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.
• Participation in FRENCH.MRD.CRC part 1 - SURGERY
• Colorectal cancer, UICC stage III
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, Hérault, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA analysis NGS on tumor specimen

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Neoplasm, Residual

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Thomas BARDOL, M.D.

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Catherine ALIX-PANABIERES, Ph.D.

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Catherine ALIX-PANABIERES, PhD

CONTACT

+33411759931; c-panabieres@chu-montpellier.fr

Thomas BARDOL, M.D.

CONTACT

+33467339069; t-bardol@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 1, 2024
• Study Start: April 11, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

FR (1)