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

Launched by UNICANCER · Nov 25, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the experiences of people with a specific type of metastatic colorectal cancer (mCRC) that has a BRAFV600E mutation. The researchers want to collect information and biological samples from participants to learn more about how this cancer behaves and how well different treatments work. The goal is to gather real-world data on patients' treatments and survival outcomes, which can help improve future care for others with this condition.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with BRAFV600E-mutated metastatic colorectal cancer. They should either not have received any chemotherapy for their cancer yet or have just started their first round of treatment (excluding a specific combination treatment). Participants will need to provide a tumor tissue sample for research and give their consent to join the study. Those who take part can expect to help contribute valuable information that could benefit future patients. It's important to note that participants should not have any other active cancers or conditions that might affect their ability to complete the study.

Gender

ALL

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.

Trial Officials