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New treatment option for Metastatic Colorectal Cancer
Official title A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT05639413
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women aged 18 years or older
- Histologically confirmed BRAFV600E metastatic colorectal cancer (mCRC), chemotherapy-naive in the metastatic setting or having initiated a first line...
- Available tumor tissue sample obtained before inclusion with sufficient tissue left for biological studies. Patients with only fine-needle...
- Known MMR/microsatellite status (immunohistochemistry [IHC] and polymerase chain reaction [PCR]) (or under analysis)
- Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their...
You likely can't join if
- Patient with another cancer concomitantly with the mCRC requiring treatment or influencing the prognosis according to the medical staff.
- Patients for whom the follow-up will not be assured by the investigator or its team.
- Any condition that may jeopardize patient participation in the study as well as non-contraception for men and women with child-bearing potential, and...
- Persons deprived of their liberty or under protective custody or guardianship.
See the full eligibility criteria
- Men and women aged 18 years or older
- 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...
- Available tumor tissue sample obtained before inclusion with sufficient tissue left for biological studies. Patients with only fine-needle aspirations are not eligible.
- Known MMR/microsatellite status (immunohistochemistry [IHC] and polymerase chain reaction [PCR]) (or under analysis)
- 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...
- Patients must be willing and able to comply with the study procedures
- The patient must be affiliated to a social security system or benefit of such a system.
- Patient with another cancer concomitantly with the mCRC requiring treatment or influencing the prognosis according to the medical staff.
- Patients for whom the follow-up will not be assured by the investigator or its team.
- 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.
- Persons deprived of their liberty or under protective custody or guardianship.
The study team makes the final eligibility decision.
Where it's taking place
- Avignon, France
- Bayeux, France
- Beauvais, France
- Bordeaux, France
- Bourg-en-Bresse, France
- Cahors, France
- Calais, France
- Caluire-et-Cuire, France
- Clermont-Ferrand, France
- Creil, France
- Créteil, France
- Grenoble, France
- La Tronche, France
- Le Coudray, France
- Le Puy-en-Velay, France
- Levallois-Perret, France
- Limoges, France
- Lyon, France
- Marseille, France
- Meaux, France
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avignon, France; Bayeux, France; Beauvais, France; Bordeaux, France; Bourg-en-Bresse, France; Cahors, France and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.