Status:

RECRUITING

A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer

Lead Sponsor:

UNICANCER

Collaborating Sponsors:

Pierre Fabre Medicament

Conditions:

Metastatic Colorectal Cancer

BRAF V600E Mutation Positive

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The study will be conducted in patients with metastatic colorectal cancer (mCRC) harboring a BRAFV600E mutation, to collect clinical data and biological samples to be used for research but also to gat...

Detailed Description

Despite substantial progress made in the first- and second line mCRC settings, there are still unmet clinical needs for patients harboring BRAFV600E mutations, especially those with microsatellite sta...

Eligibility 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.

Key Trial Info

Start Date :

July 24 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2028

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT05639413

Start Date

July 24 2023

End Date

July 1 2028

Last Update

December 10 2025

Active Locations (45)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 12 (45 locations)

1

Centre Hospitalier D'Avignon

Avignon, France, 84000

2

Centre Hospitalier de Bayeux

Bayeux, France, 14400

3

Chu Simone Veil

Beauvais, France

4

Institut Bergonie

Bordeaux, France, 33076