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Collecting data from patients with BRAFV600E-mutated metastatic colorectal cancer

A Study to Collect Patients, Medical, and Biological Data From Patients Being Treated for Metastatic Colorectal Cancer With a Specific Genetic Mutation: BRAFV600E

Not applicable Interventional Unicancer · NCT05639413

This study is collecting information and samples from patients with a specific type of metastatic colorectal cancer to see how well different treatments work and what factors affect their outcomes.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorUnicancer Academic / other
Drugs / interventionscetuximab, chemotherapy, immunotherapy
Locations45 sites (Avignon and 44 other locations)
Trial IDNCT05639413 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with metastatic colorectal cancer (mCRC) who have a BRAFV600E mutation. It aims to collect clinical data and biological samples to better understand treatment outcomes and survival rates in this specific patient population. The study will gather real-world data on treatment responses and resistance mechanisms, particularly in patients with microsatellite stable tumors. By analyzing tumor tissue and blood samples, researchers hope to identify predictive and prognostic biomarkers that can inform future therapeutic decisions.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18 and older with histologically confirmed BRAFV600E metastatic colorectal cancer who are chemotherapy-naive or have just started their first line of chemotherapy.

Not a fit: Patients who have previously received encorafenib-cetuximab treatment or those with only fine-needle aspiration samples will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with BRAFV600E-mutated metastatic colorectal cancer.

How similar studies have performed: While there have been studies on metastatic colorectal cancer, this specific focus on BRAFV600E mutations and real-world data collection is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Men and women aged 18 years or older
2. Histologically confirmed BRAFV600E metastatic colorectal cancer (mCRC), chemotherapy-naive in the metastatic setting or having initiated a first line of chemotherapy in the metastatic setting (except encorafenib-cetuximab treatment)
3. Available tumor tissue sample obtained before inclusion with sufficient tissue left for biological studies. Patients with only fine-needle aspirations are not eligible.
4. Known MMR/microsatellite status (immunohistochemistry \[IHC\] and polymerase chain reaction \[PCR\]) (or under analysis)
5. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not related to the investigator or the sponsor, can confirm in writing the patient's consent.
6. Patients must be willing and able to comply with the study procedures
7. The patient must be affiliated to a social security system or benefit of such a system.

Exclusion Criteria:

1. Patient with another cancer concomitantly with the mCRC requiring treatment or influencing the prognosis according to the medical staff.
2. Patients for whom the follow-up will not be assured by the investigator or its team.
3. Any condition that may jeopardize patient participation in the study as well as non-contraception for men and women with child-bearing potential, and pregnancy or breast feeding for women.
4. Persons deprived of their liberty or under protective custody or guardianship.

Where this trial is running

Avignon and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Colorectal CancerBRAF V600E Mutation PositiveClinical-biological cohortColorectal CancerBRAF mutation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.