French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM)

NCT06287723 | Not Yet Recruiting

• 1 other identifier: RECHMPL23_0297
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.CRLM is the French study and part of the european GUIDE.MRD project.

Conditions

Colorectal Cancer; Liver Metastases; Stage IV Colorectal Cancer; Minimal Residual Disease; Liquid Biopsy; ctDNA

Keywords

Stage IV colorectal cancer; Minimal Residual Disease; Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival

  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-year after the end of inclusion

Secondary Outcomes (8)

• Sensitivity (Se) of the ctDNA diagnostics

  3 years after the end of inclusion

• Specificity (Sp) of the ctDNA diagnostics

  3 years after the end of inclusion

• Positive predictive value of the ctDNA diagnostics

  3 years after the end of inclusion

• Negative predictive value of the ctDNA diagnostics

  3 years after the end of inclusion

• Area under the curve of the ctDNA diagnostics

  3 years after the end of inclusion

Study Arms (1)

Stage IV colorectal liver metastasis patients

Stage IV colorectal liver metastasis patients treated with curative intent

Biological: Blood sample/Liquid biopsy

Interventions

Blood sample/Liquid biopsy BIOLOGICAL

ctDNA analysis

Stage IV colorectal liver metastasis 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

Patients with resectable colorectal liver metastasis

You may qualify if:

• Patient 18 years or older.
• Colorectal cancer liver metastasis or metastases, according to the assessment of the MDT.
• Metachronous and synchronous metastases will be included, as long as treatment intention of metastases resection is curative. In case of rare instances, where the liver metastases is removed before surgery of the primary tumor, postOP ctDNA is collected when the patient is considered completely tumor-free, i.e. after complete surgery of both the liver metastases and the primary tumor.
• Treatment is planned with curative intent (patients treated with RFA can be included, BUT in these cases a tissue sample from the primary CRC tumor is a requisite)

You may not qualify if:

• Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.
• Extrahepatic metastases
• Malignant colorectal polyps diagnosed after polypectomy.
• 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.
• Liver cirrhosis
• CRLM intervention/surgery cannot be/was not performed with curative intent
• No tumor tissue available (preferably CRLM lesion, or alternatively primary tumor)
• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA analysis NGS on tumor specimen

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm, Residual

Interventions

Blood Specimen Collection; Liquid Biopsy

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; Biopsy; Cytodiagnosis; Cytological 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, Ph.D.

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: March 1, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2028
• Last Updated: March 1, 2024

Record last verified: 2024-02