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Researchers launch study to track Real-World outcomes in BRAF-Mutated colorectal cancer

NCT ID NCT05639413

Knowledge-focused Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is collecting medical information and blood samples from 400 people with metastatic colorectal cancer that has a specific genetic change called BRAFV600E. The goal is to learn more about how this cancer is treated in everyday practice and what outcomes patients experience. Participants will provide blood samples at various timepoints, and researchers will follow their health over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help researchers better understand how BRAFV600E metastatic colorectal cancer behaves and how it is currently treated in real-world settings.
What could go wrong
This is an observational study, not a treatment trial. It will not test a new therapy or directly improve patient outcomes. Results may take years to influence clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRAF V600E mutation positive Metastatic colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aphp - Hopital Bichat

    RECRUITING

    Paris, 75013, France

  • Aphp - Hopital Henri Mondor

    RECRUITING

    Créteil, France

  • Aphp - Hopital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Aphp - La Pitie Salpetriere

    RECRUITING

    Paris, 75013, France

  • CH Dr TECHER

    ACTIVE_NOT_RECRUITING

    Calais, 62107, France

  • CH Fleyriat

    ACTIVE_NOT_RECRUITING

    Bourg-en-Bresse, 01000, France

  • CH Louis Pasteur

    NOT_YET_RECRUITING

    Le Coudray, 28630, France

  • CHR d'Orléans

    ACTIVE_NOT_RECRUITING

    Orléans, 45100, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, France

  • Centre Hospitalier D'Avignon

    ACTIVE_NOT_RECRUITING

    Avignon, 84000, France

  • Centre Hospitalier de Bayeux

    RECRUITING

    Bayeux, 14400, France

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Centre Paul Strauss

    RECRUITING

    Strasbourg, 67033, France

  • Centre d'Oncologie Saint Yves

    RECRUITING

    Vannes, 56000, France

  • Ch Perpignan

    RECRUITING

    Perpignan, France

  • Ch de Cahors

    RECRUITING

    Cahors, France

  • Ch de Saint Malo

    ACTIVE_NOT_RECRUITING

    St-Malo, France

  • Chru de Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • Chu Dupuytren

    RECRUITING

    Limoges, 87042, France

  • Chu Estaing de Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63003, France

  • Chu Poitiers

    RECRUITING

    Poitiers, 86021, France

  • Chu Rennes Pontchaillou

    RECRUITING

    Rennes, 35000, France

  • Chu Simone Veil

    ACTIVE_NOT_RECRUITING

    Beauvais, France

  • Chu de Grenoble Alpes - Hopital Michallon

    WITHDRAWN

    La Tronche, 38700, France

  • Chu de Reims

    RECRUITING

    Reims, 51100, France

  • Chu de Rouen

    RECRUITING

    Rouen, 76031, France

  • Chu de Tours

    RECRUITING

    Tours, 37044, France

  • GHPSO

    RECRUITING

    Creil, France

  • Gh Diaconesses Croix Saint Simon

    RECRUITING

    Paris, 75020, France

  • Grand Hopital de L'Est Francilien - Site de Meaux

    ACTIVE_NOT_RECRUITING

    Meaux, France

  • Groupe Hospitalier Emile Roux

    RECRUITING

    Le Puy-en-Velay, France

  • Groupe Hospitalier Mutualiste de Grenoble

    WITHDRAWN

    Grenoble, 38028, France

  • Hnia Begin

    ACTIVE_NOT_RECRUITING

    Saint-Mandé, France

  • Hnia Saint Anne

    NOT_YET_RECRUITING

    Toulon, France

  • Hopital Europeen Georges Pompidou

    RECRUITING

    Paris, France

  • Hopital Franco-Britannique

    ACTIVE_NOT_RECRUITING

    Levallois-Perret, 92300, France

  • Hopital Saint Antoine

    RECRUITING

    Paris, 75012, France

  • Hopital de La Timone

    NOT_YET_RECRUITING

    Marseille, France

  • Hôpital Privé de la Loire

    ACTIVE_NOT_RECRUITING

    Saint-Etienne, 42100, France

  • Hôpital privé Jean Mermoz

    ACTIVE_NOT_RECRUITING

    Lyon, 69373, France

  • Infirmerie Protestante de Lyon

    ACTIVE_NOT_RECRUITING

    Caluire-et-Cuire, France

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Institut Mutualiste Montsouris

    RECRUITING

    Paris, 75014, France

  • Institut de Cancerologie de Lorraine

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, France

  • Intitut Paoli Calmettes

    RECRUITING

    Marseille, France

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