Collecting data from patients with BRAFV600E-mutated metastatic 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

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier de Bayeux
  Bayeux, France Recruiting
• Institut Bergonie
  Bordeaux, France Recruiting
• Ch de Cahors
  Cahors, France Recruiting
• Chu Estaing de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Ghpso
  Creil, France Recruiting
• Aphp - Hopital Henri Mondor
  Créteil, France Recruiting

Study contacts

• Principal investigator: Christelle DE LA FOUCHARDIERE, MD — Centre Leon Berard - Lyon
• Study coordinator: Emilie BRUMENT
• Email: e-brument@unicancer.fr
• Phone: +33(0)1 71 93 61 64

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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.