RecruitingNAINTERVENTIONAL

Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms

This study is investigating digestive cancers, such as bowel and pancreatic cancer. Researchers want to understand how different things, like your body's immune system, the tiny environment around the cancer cells, and even the bacteria in your gut, might affect how these cancers develop and respond to treatment. By looking at these complex relationships, they hope to find better ways to predict how well patients will do and how effective treatments like chemotherapy or immunotherapy might be. They're gathering information from many patients over a long period. This will help them learn more about why some people respond differently to treatments and ultimately, improve care for people with digestive cancers.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

6,300

Start

13 Jan 2021

Estimated completion

01 Jan 2031

Gastrointestinal Neoplasms

What is this study about?

This important research study is looking closely at cancers of the digestive system, which include common types like bowel cancer, as well as pancreatic and bile duct cancers. The main goal is to understand the complex ways your body, the tiny area around the cancer (the 'microenvironment'), and your body's natural defence system (immunity) interact with these cancers. Think of it like trying to solve a puzzle where each piece – your genes, your immune system, the bacteria in your gut, and even how your body processes food – plays a role in how cancer behaves.

Researchers want to see if these different factors can help predict how well a patient might respond to various treatments, such as surgery, chemotherapy, or newer treatments like immunotherapy. They also want to understand if these factors can predict how the cancer might progress over time. By gathering information from many patients, they hope to find patterns that will lead to more effective and personal treatments in the future.

This study is happening in one hospital in France and involves looking at past patient information as well as collecting new information from patients diagnosed in the coming years. It's a long-term study that will follow patients for many years to gain the fullest picture possible. Importantly, if you take part, your usual medical care and treatment choices will not change; these decisions will still be made by your doctors based on what's best for you.

Key takeaways

Aims to understand digestive cancers better using your body's information.
Will collect blood, stool, and potentially liver tissue samples.
Your medical treatment will not change if you participate.
Participation will help researchers learn for future patients.
You can leave the study whenever you want.
The study is based in France and requires French social security affiliation.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. You must have been diagnosed with a digestive cancer, such as bowel, pancreatic, bile duct, or stomach/gullet cancer. This diagnosis needs to be confirmed by a doctor, no matter how advanced your cancer is.

Importantly, you would need to be part of the French social security system. If you are diagnosed between 1998 and 2030, you might be eligible. If you're no longer alive, your past information might still be used if it fits the study's needs.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding (for the ongoing part of the study), or if you are under special legal protection due to being unable to make your own decisions. If your doctor feels there's any reason you might find it difficult to stick with the study plan, or if you simply prefer not to take part, then you wouldn't be included.

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 at least 18 years old?
Have you been diagnosed with a digestive cancer (e.g., bowel, pancreatic, bile duct, or stomach/gullet cancer)?
Are you affiliated with the French social security system?
Are you not currently pregnant or breastfeeding (for new participants)?
Have you confirmed you are not under legal guardianship preventing you from giving consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you wouldn't have any changes to your usual medical care. All your treatments, like surgery, chemotherapy, or radiotherapy, will be chosen by your doctors, just as they would be normally, following standard hospital guidelines.

The study involves collecting some extra samples and information. This could include having blood samples taken, a liver biopsy (where a small piece of tissue is removed from your liver for examination), and providing stool (poo) samples. These are done to help researchers understand more about your cancer and your body's response.

This is a long-term study, and patients may be followed for up to 10 years, depending on when they join. The specific frequency of visits for samples would be discussed with you, but the key is that the study aims to gather information over time without changing your direct medical treatment.

Potential risks and benefits

Taking part in this study won't directly improve your personal health, as it's about gathering information to help future patients. However, the potential benefit is contributing valuable knowledge that could lead to better understandings and treatments for digestive cancers in the future. As for risks, any procedures like blood tests or liver biopsies carry small, standard risks such as bruising or discomfort, which your doctor will explain fully. Providing stool samples is generally risk-free. You have the right to withdraw from the study at any time, without giving a reason, and this will not affect your medical care.

Locations (1)

Digestive Surgery Department, Ambroise Paré Hospital, APHP
Verified postcode
Boulogne-Billancourt, France· Recruiting

Common questions

Will my treatment change if I join this study?

No, your medical treatment will not change. Your doctors will continue to make all decisions about your care based on what's best for you, following standard hospital guidelines.

What kind of samples will the study collect from me?

The study may ask for blood samples, stool (poo) samples, and potentially a liver biopsy (a small tissue sample from your liver).

How long will I be involved in the study?

Patients can be followed for up to 10 years, depending on when they join the study. Your initial diagnosis determines the follow-up period.

Do I need to travel if I join the study?

This study is happening at Ambroise Paré Hospital in France. You would need to be a patient there and affiliated with the French social security system.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Frédérique PESCHAUD, MD, PhD

frederique.peschaud@aphp.fr +33 1 49 09 53 35 Official trial record

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