Actively Recruiting
A Study to Collect Patients, Medical, and Biological Data From Patients Being Treated for Metastatic Colorectal Cancer With a Specific Genetic Mutation: BRAFV600E
Led by UNICANCER · Updated on 2025-12-10
400
Participants Needed
45
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
P
Pierre Fabre Medicament
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating metastatic colorectal cancer (mCRC) patients who have a specific genetic change called the BRAFV600E mutation. This rare subtype of mCRC often shows poor response to current treatments and has a generally poor outlook. The study aims to collect detailed clinical data and biological samples to better understand this condition, including how patients respond to treatments and what factors predict their survival. It focuses on real-world treatment outcomes and biological markers that might influence therapy choices and resistance. Participants will provide blood samples at multiple times during their treatment, including before and during the first three treatment cycles, at 3 and 6 months after starting each treatment line, and when disease progression occurs following certain therapies. The study gathers up to 390 mL of blood per participant over time to analyze circulating tumor DNA and immune environment factors. This observational approach will help researchers identify biomarkers related to treatment response and disease progression. During the study, participants' clinical progress and survival will be tracked for up to five years. Researchers will review overall survival from diagnosis to death and assess how prognostic markers relate to progression-free survival and response to treatments. The study involves collecting tumor tissue samples and blood tests, along with routine follow-up visits. All data collected will contribute to understanding BRAFV600E mCRC and improving future treatment strategies.
CONDITIONS
Brief Title
A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Histologically confirmed BRAFV600E metastatic colorectal cancer, chemotherapy-naive in metastatic setting or started first-line chemotherapy (except encorafenib-cetuximab treatment)
- Available tumor tissue sample obtained before inclusion with enough tissue for biological studies; fine-needle aspirations not eligible
- Known mismatch repair or microsatellite status (immunohistochemistry and PCR) or status under analysis
- Signed written informed consent or consent confirmed by a trusted person if patient unable
- Willing and able to comply with study procedures
- Affiliated with a social security system or equivalent
You will not qualify if you...
- Having another cancer requiring treatment or affecting prognosis concurrently with metastatic colorectal cancer
- Follow-up cannot be assured by the investigator or team
- Any condition that risks participation, including lack of contraception for those with child-bearing potential, pregnancy, or breastfeeding
- Being under protective custody, guardianship, or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who are being treated for BRAFV600E metastatic colorectal cancer have blood samples collected and clinical data recorded to evaluate disease progression and response to treatment.
Blood samples collected at the start of cycles 1, 2, and 3; at 3 and 6 months after starting each treatment line; and at disease progression after specific treatments, if applicable
Trial Site Locations
Total: 45 locations
1
Centre Hospitalier D'Avignon
Avignon, France, 84000
Active, Not Recruiting
2
Centre Hospitalier de Bayeux
Bayeux, France, 14400
Actively Recruiting
3
Chu Simone Veil
Beauvais, France
Active, Not Recruiting
4
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
5
CH Fleyriat
Bourg-en-Bresse, France, 01000
Active, Not Recruiting
6
Ch de Cahors
Cahors, France
Actively Recruiting
7
CH Dr TECHER
Calais, France, 62107
Active, Not Recruiting
8
Infirmerie Protestante de Lyon
Caluire-et-Cuire, France
Active, Not Recruiting
9
Chu Estaing de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Actively Recruiting
10
GHPSO
Creil, France
Actively Recruiting
11
Aphp - Hopital Henri Mondor
Créteil, France
Actively Recruiting
12
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France, 38028
Withdrawn
13
Chu de Grenoble Alpes - Hopital Michallon
La Tronche, France, 38700
Withdrawn
14
CH Louis Pasteur
Le Coudray, France, 28630
Not Yet Recruiting
15
Groupe Hospitalier Emile Roux
Le Puy-en-Velay, France
Actively Recruiting
16
Hopital Franco-Britannique
Levallois-Perret, France, 92300
Active, Not Recruiting
17
Chu Dupuytren
Limoges, France, 87042
Actively Recruiting
18
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
19
Hôpital privé Jean Mermoz
Lyon, France, 69373
Active, Not Recruiting
20
Hopital de La Timone
Marseille, France
Not Yet Recruiting
21
Intitut Paoli Calmettes
Marseille, France
Actively Recruiting
22
Grand Hopital de L'Est Francilien - Site de Meaux
Meaux, France
Active, Not Recruiting
23
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
24
CHR d'Orléans
Orléans, France, 45100
Active, Not Recruiting
25
Aphp - Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
26
Hopital Saint Antoine
Paris, France, 75012
Actively Recruiting
27
Aphp - Hopital Bichat
Paris, France, 75013
Actively Recruiting
28
Aphp - La Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
29
Institut Mutualiste Montsouris
Paris, France, 75014
Actively Recruiting
30
Gh Diaconesses Croix Saint Simon
Paris, France, 75020
Actively Recruiting
31
Hopital Europeen Georges Pompidou
Paris, France
Actively Recruiting
32
Ch Perpignan
Perpignan, France
Actively Recruiting
33
Chu Poitiers
Poitiers, France, 86021
Actively Recruiting
34
Chu de Reims
Reims, France, 51100
Actively Recruiting
35
Chu Rennes Pontchaillou
Rennes, France, 35000
Actively Recruiting
36
Chu de Rouen
Rouen, France, 76031
Actively Recruiting
37
Hôpital Privé de la Loire
Saint-Etienne, France, 42100
Active, Not Recruiting
38
Hnia Begin
Saint-Mandé, France
Active, Not Recruiting
39
Ch de Saint Malo
St-Malo, France
Active, Not Recruiting
40
Centre Paul Strauss
Strasbourg, France, 67033
Actively Recruiting
41
Hnia Saint Anne
Toulon, France
Not Yet Recruiting
42
Chu de Tours
Tours, France, 37044
Actively Recruiting
43
Chru de Nancy
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
44
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
45
Centre d'Oncologie Saint Yves
Vannes, France, 56000
Actively Recruiting
Research Team
E
Emilie BRUMENT
A
Anne-Sophie BACH, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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