RecruitingNAINTERVENTIONAL

A Clinicobiological Database in Metastatic Digestive Cancers

This study is building a valuable collection of blood samples from patients with digestive cancers that have spread to other parts of the body (metastatic). Blood will be collected before and during treatment. By studying these samples, researchers hope to understand why certain treatments work better for some patients than others. The goal is to discover new ways to predict how well treatments will work and to monitor their effectiveness, making cancer care more individualised. Ultimately, this could lead to more effective and personalised treatment strategies for people with these types of cancer, improving their chances of a better outcome.

At a glance

Status

Recruiting

Phase

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

200

Start

12 Sep 2016

Estimated completion

01 Sep 2031

Digestive System Neoplasm

What is this study about?

Digestive cancers, which include cancers of the bowel, pancreas, stomach, and oesophagus, are unfortunately quite common. When these cancers spread to other parts of the body, they are called metastatic digestive cancers. Patients usually receive treatments like chemotherapy, sometimes combined with other targeted drugs, to help control the cancer and improve their health. However, figuring out which treatment will work best for each person can be tricky. Doctors often lack clear indicators, called biomarkers, that can tell them in advance if a treatment will be effective or if the cancer might become resistant to it.

Currently, to decide on the best treatment, doctors sometimes look for specific changes (mutations) in tumour tissue. This usually involves a biopsy, which is a small operation to remove a piece of tissue. While helpful, biopsies can be uncomfortable and aren't always easy to repeat if doctors want to check on changes over time. This study aims to find new and easier ways to personalise cancer treatment.

The main idea is to create a special collection of blood samples. Blood tests are much easier to do and can be repeated more often than biopsies. By collecting blood from patients with advanced digestive cancers both before and during their initial treatments, researchers can look for new biomarkers. These blood biomarkers could help doctors predict which treatments will be most effective for each patient, monitor how well a treatment is working, and spot if the cancer is becoming resistant. Ultimately, this could lead to more tailored and effective care for people living with metastatic digestive cancers.

Key takeaways

This study is collecting blood samples for future cancer research.
It focuses on advanced digestive cancers that have spread.
The goal is to find better ways to personalise cancer treatments.
You will not receive new medication or different treatments as part of this study.
Participation involves providing blood samples before and during your regular treatment.
Your contribution could help improve care for future patients with similar cancers.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. You should have a confirmed diagnosis of adenocarcinoma, which is a type of cancer that starts in glandular cells, in your colon, rectum, small bowel, pancreas, stomach, bile duct, or oesophagus. The cancer needs to have spread to other parts of your body, and you must be scheduled to start your first or second course of chemotherapy or targeted therapy for this advanced cancer.

There are also some reasons why you wouldn't be able to join. You can't participate if you are under 18 or if your cancer is not an adenocarcinoma type. If you have already started your first or second course of chemotherapy or targeted therapy for your metastatic cancer, you won't be eligible. Also, pregnant or breastfeeding women cannot take part.

Finally, if you are currently involved in another early-stage (Phase I-II) clinical trial that involves extra blood tests or changes your usual treatment, you would not be able to join this study. It's also important that you are part of a social security system and that your doctors can easily keep track of your progress for the study, meaning no major difficulties due to personal circumstances.

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 a diagnosis of adenocarcinoma in your colon, rectum, small bowel, pancreas, stomach, bile duct, or oesophagus?
Has your cancer spread to other parts of your body?
Are you about to start your first or second course of chemotherapy or targeted therapy for your advanced cancer?
Are you not currently pregnant or breastfeeding?
Are you not in another early-stage clinical trial that significantly changes your treatment or involves many extra blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main involvement will be providing blood samples. These samples will be collected at key points during your treatment journey for your metastatic digestive cancer. Specifically, blood will be taken before you start your first or second line of chemotherapy or targeted therapy, and then at specific times while you are receiving that treatment. This is to gather information on how your body and the cancer react at different stages.

This study does not involve any new medications or changes to your existing treatment plan for your cancer; you will receive the standard care your doctor has prescribed. There are no additional hospital visits required beyond your usual appointments for cancer treatment. The total duration of your participation will depend on how long you receive your first and second lines of treatment for metastatic cancer, as samples are collected during these periods and then potentially analysed later. However, the sample collection itself aligns with your ongoing treatment schedule.

Potential risks and benefits

The main benefit of taking part is that the information from your blood samples could help future patients by leading to better, more personalised cancer treatments. There is no direct personal benefit to you from participating, as this study focuses on collecting samples for future research, not providing new treatment. The risks are minimal, primarily those associated with standard blood draws, such as slight pain, bruising, or a small risk of infection at the site where blood is taken. You are free to withdraw from the study at any time without giving a reason, and this will not affect the quality of your medical care.

Locations (1)

Institut régional du cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What kind of cancer does this study focus on?

This study is for people with advanced cancers of the digestive system, such as those affecting the bowel, stomach, or pancreas, that have spread to other parts of the body.

Will I receive any new treatments in this study?

No, this study is about collecting blood samples for future research. You will continue to receive the standard treatments your doctor has prescribed for your cancer.

How often will I need to give blood samples?

Blood samples will be taken before you start your first or second round of cancer treatment and at specific times during that treatment, usually coinciding with your regular appointments.

What will my blood samples be used for?

Your blood samples will be stored in a collection and used by researchers to find better ways to predict which treatments work best and to monitor cancer changes over time, aiming for more personalised care.

Can I leave the study at any point?

Yes, you are completely free to leave the study at any time without giving a reason. Your decision will not affect your medical care.

How to find out more

Aurore MOUSSION

jean-pierre.bleuse@icm.unicancer.fr 4 67 61 31 02 Official trial record

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