Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05639413

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

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

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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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