RecruitingOBSERVATIONAL

COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

The COLON-IM study aims to understand more about bowel cancer by looking closely at your bowel tissue. Researchers will examine how bacteria in your gut (called microbiota) and immune cells, which are part of your body's defence system, behave in both healthy tissue and cancerous growths. We know that bowel cancer is common and that the gut bacteria of people with bowel cancer can be different from healthy people. By studying these factors, the research hopes to uncover new ways that bowel cancer develops and spreads. This information could help doctors find better ways to diagnose, treat, and even prevent bowel cancer in the future, particularly by identifying new targets for treatments like immunotherapy.

At a glance

Status

Recruiting

Sponsor

Centre Leon Berard

Enrolment target

400

Start

02 May 2019

Estimated completion

01 Dec 2029

Colorectal Cancer

What is this study about?

This study, called COLON-IM, is focused on understanding bowel cancer, which is a very common type of cancer in Europe and the US. The researchers want to learn more about how our body's natural defences, called the immune system, and the bacteria that live in our gut (known as microbiota) might play a role in developing bowel cancer.

They will be looking at samples of bowel tissue from people with different stages of bowel cancer, as well as those with non-cancerous growths. By examining the types of immune cells and bacteria present in these tissues, they hope to get a clearer picture of how these elements interact with cancer cells. For example, some studies have shown that certain bacteria can influence how well immunotherapy treatments work, which are treatments that boost your body's immune system to fight cancer.

Understanding these connections could lead to exciting new discoveries. It might help doctors find new 'targets' for medicines, develop better ways to predict how a cancer will behave, or even help guide which treatments would be most effective for individual patients. The ultimate goal is to improve the care and outcomes for people with bowel cancer.

Key takeaways

Study examines gut bacteria and immune cells in bowel cancer.
Aims to improve future understanding and treatment of bowel cancer.
Uses tissue samples from planned bowel surgery.
Does not involve new treatments or procedures for participants.
Participation could help future patients with bowel cancer.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old.

The study is looking for two main groups of people. Cohort A includes patients who have not yet received any cancer treatment (like chemotherapy or radiotherapy) and are undergoing surgery for either a benign growth or bowel cancer at stages 1 to 3. Cohort B is for patients with localised bowel cancer who are having surgery after receiving radiotherapy or chemotherapy before their operation.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, if you've had certain immune-modifying medications or antibiotics recently, or if you have a serious inflammatory or autoimmune disease. Patients who have been treated for another type of cancer more than a year ago might still be able to participate, if there are no signs of the previous cancer returning.

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?
Are you having surgery for a benign or cancerous bowel growth?
Have you *not* had prior anti-cancer treatment (if you are in Cohort A)?
Are you *not* pregnant or breastfeeding?
Have you *not* received certain immune-affecting medicines or antibiotics recently?
Do you *not* have a serious inflammatory or autoimmune disease?

Answer every question to see your result.

What does participation involve?

The information provided does not detail specific study visits, assessments, medication, or the total duration of participation. Generally, in studies like this, if you are having surgery for bowel issues, researchers would typically ask to use a small part of the tissue removed during your operation for their tests. You would also give your consent to allow them to collect and study this tissue, along with some of your medical information, to help with their research goals.

Potential risks and benefits

Participating in this study involves using tissue that would already be removed during your planned surgery, so it does not add extra procedures or risks related to the tissue collection itself. The potential benefit is that the knowledge gained from your tissue and information could help improve future understanding and treatments for bowel cancer. There are no direct personal benefits from taking part in terms of treatment. You always have the right to withdraw from the study at any time, even if you’ve initially agreed to participate, without affecting your medical care.

Locations (3)

Hopital Saint Joseph Saint Luc
Verified postcode
Lyon, France· Recruiting
Clinique de L'Infirmerie Protestante
Verified postcode
Lyon, France· Recruiting
Centre Leon Berard
Verified postcode
Lyon, France· Recruiting

Common questions

What is the main goal of the COLON-IM study?

The main goal is to understand how gut bacteria and immune cells in bowel tissue might be involved in the development of bowel cancer.

Will I receive any new treatments as part of this study?

No, this study is observational, meaning it collects and examines tissue and data. It does not involve new treatments for participants.

What kind of tissue will be studied?

Researchers will study samples of bowel tissue that are already being removed during your surgery, both from any growths and surrounding healthy areas.

What is 'microbiota'?

Microbiota refers to the community of tiny living organisms, like bacteria, that naturally live in your gut.

Who is funding this research?

The information provided does not specify the funding source. This type of information is usually available in the full study protocol.

How to find out more

Gwenaelle GARIN

gwenaelle.garin@lyon.unicancer.fr 04 26 55 68 24 Official trial record

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