RECRUITINGINTERVENTIONAL
A Clinical-biological Prospective Cohort of 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
About This Trial
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 gather real-world clinical data concerning the treatments and the survival outcomes in patients with this pathology.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Men and women aged 18 years or older
2. diagnosed by tissue sample (biopsy-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 willing to sign a consent form 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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
Collection of blood samples
A 30 mL blood samples (6 mL in each of 5 EDTA tubes) will be collected from each patient at each timepoint.
Locations (20)
Centre Hospitalier D'Avignon
Avignon, France
Centre Hospitalier de Bayeux
Bayeux, France
Chu Simone Veil
Beauvais, France
Institut Bergonie
Bordeaux, France
CH Fleyriat
Bourg-en-Bresse, France
Ch de Cahors
Cahors, France
CH Dr TECHER
Calais, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, France
Chu Estaing de Clermont-Ferrand
Clermont-Ferrand, France
GHPSO
Creil, France
Aphp - Hopital Henri Mondor
Créteil, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Chu de Grenoble Alpes - Hopital Michallon
La Tronche, France
CH Louis Pasteur
Le Coudray, France
Groupe Hospitalier Emile Roux
Le Puy-en-Velay, France
Hopital Franco-Britannique
Levallois-Perret, France
Chu Dupuytren
Limoges, France
Centre Leon Berard
Lyon, France
Hôpital privé Jean Mermoz
Lyon, France
Hopital de La Timone
Marseille, France