RecruitingNAINTERVENTIONAL

A Clinical-biological Prospective Cohort of Patients With BRAFV600E-mutated Metastatic Colorectal Cancer

This study focuses on people in the UK who have advanced bowel cancer (metastatic colorectal cancer) with a specific genetic change in their tumour called a BRAFV600E mutation. The main aim is to gather important health information and blood samples from these patients. This includes looking at the different treatments people receive and how well they work over time. By collecting this 'real-world' information, researchers hope to better understand this particular type of bowel cancer, including why some treatments stop working. The goal is to find better ways to decide on treatments and predict how the disease might progress for patients in the future.

At a glance

Status

Recruiting

Phase

Sponsor

UNICANCER

Enrolment target

400

Start

24 Jul 2023

Estimated completion

01 Jul 2028

Metastatic Colorectal Cancer BRAF V600E Mutation Positive

What is this study about?

This study is for adults with advanced bowel cancer, also known as metastatic colorectal cancer. This means the cancer has spread from where it started. Specifically, it's for people whose cancer cells have a particular change in their DNA called a BRAFV600E mutation. This mutation makes the cancer behave differently from other types of bowel cancer.

Currently, we don't know enough about how this specific type of advanced bowel cancer affects people's lives in the UK, what treatments are commonly used, and how well those treatments work over time. The study aims to fill these gaps in our knowledge by collecting information about people's health and treatments, as well as blood and tissue samples. The researchers will look closely at these samples to find new clues about how the cancer grows and why some treatments might stop working.

The information gathered from this study will be used to improve our understanding of BRAFV600E-mutated advanced bowel cancer. This includes trying to find special markers (biomarkers) in the blood and tumour that could help doctors choose the best treatments, predict how the disease might respond to treatment, and understand how it might progress. Ultimately, this research hopes to lead to better care and outcomes for patients with this form of bowel cancer.

Key takeaways

This study is for adults with advanced bowel cancer (metastatic colorectal cancer) with a specific BRAFV600E genetic change.
It collects health information and blood samples to understand this cancer better.
This is an 'observational' study, meaning you won't receive new treatments through it.
The goal is to find better ways to guide treatment decisions and predict how the cancer will respond.
Your participation could help future patients with this type of cancer.

Who may be eligible?

To join this study, you must be 18 years old or older and have a specific type of advanced bowel cancer (metastatic colorectal cancer) that has a genetic change called a BRAFV600E mutation. You can be newly diagnosed with advanced cancer and not yet started chemotherapy, or you might have already started your first round of chemotherapy for advanced cancer (but not a specific drug combination called encorafenib-cetuximab).

It’s also important that there's a sample of your tumour tissue available from a past biopsy that researchers can use for their studies. Your doctors will also need to know the specific 'MMR/microsatellite status' of your cancer, which helps them understand more about its features. You must be able and willing to follow the study procedures and provide written permission to take part.

You cannot join if you have another cancer requiring treatment, or if your doctors don't think they can follow up with you regularly. Women who are pregnant or breastfeeding, or people who are not using contraception if they could have children, also cannot take part. Additionally, if someone is unable to make their own decisions freely, they won't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced bowel cancer (metastatic colorectal cancer)?
Has your cancer been tested and found to have a BRAFV600E genetic mutation?
Is a sample of your tumour tissue available for research?
Are you willing to provide blood samples and allow researchers to use your health information?
Are you able to provide written permission (informed consent) to join?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves your doctors collecting information about your health and the treatments you receive as part of your usual care. You will also be asked to provide blood samples at different times during your treatment for advanced bowel cancer. The researchers will use these samples and your health information for their studies.

There are no specific study medications involved – you will receive the treatment your doctor recommends as usual. The study will follow you through your first, second, and third lines of treatment for advanced bowel cancer, as well as tracking how you are doing over time. The total duration of your participation will depend on your treatment journey and how long the researchers need to follow your progress, but it will involve blood collections at several points.

Potential risks and benefits

The main benefit of taking part is that your medical information and blood samples could help researchers learn more about this specific type of bowel cancer, potentially leading to better understanding and treatments for future patients. You will not receive any direct personal benefit from taking part, as this is an observational study rather than a treatment trial. The main risk involves having blood samples drawn, which might cause minor bruising, discomfort, or a small risk of infection. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care or your relationship with your healthcare team.

Locations (45)

Centre Hospitalier D'Avignon
Verified postcode
Avignon, France· Active not recruiting
Centre Hospitalier de Bayeux
Verified postcode
Bayeux, France· Recruiting
Chu Simone Veil
Verified postcode
Beauvais, France· Active not recruiting
Institut Bergonie
Verified postcode
Bordeaux, France· Recruiting
CH Fleyriat
Verified postcode
Bourg-en-Bresse, France· Active not recruiting
Ch de Cahors
Verified postcode
Cahors, France· Recruiting
CH Dr TECHER
Verified postcode
Calais, France· Active not recruiting
Infirmerie Protestante de Lyon
Verified postcode
Caluire-et-Cuire, France· Active not recruiting
Chu Estaing de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
GHPSO
Verified postcode
Creil, France· Recruiting
Aphp - Hopital Henri Mondor
Verified postcode
Créteil, France· Recruiting
Groupe Hospitalier Mutualiste de Grenoble
Verified postcode
Grenoble, France· Withdrawn

Common questions

What is a 'BRAFV600E mutation'?

It's a specific change in the DNA of your cancer cells that makes the cancer behave in a particular way.

Will I receive new medicine in this study?

No, this study only collects information and blood samples. You will receive the treatment your own doctors recommend.

What does 'metastatic colorectal cancer' mean?

It means the bowel cancer has spread from its original site to other parts of your body.

How often will I need to give blood samples?

Blood samples will be taken at different points during your treatment for advanced bowel cancer, as advised by your study team.

Can I leave the study at any time?

Yes, you can withdraw from the study at any point, and it won't affect your medical care.

How to find out more

Emilie BRUMENT

e-brument@unicancer.fr +33(0)1 71 93 61 64 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.