RecruitingNAINTERVENTIONAL

Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer

Doctors are studying a new test called Immunoscore® for people who have had surgery for bowel cancer that hasn't spread (non-metastatic colorectal cancer). The main goal of this research is to see if using the Immunoscore® test helps doctors make better decisions about treatment after surgery. The test looks at the body's immune response to the cancer. Researchers want to understand if the results from this test can accurately tell them if a patient's cancer is likely to return. This could help doctors decide if someone needs more treatment, like chemotherapy, or if they might be able to avoid it. Ultimately, the study aims to improve how doctors care for patients with this type of cancer by personalising treatment recommendations.

At a glance

Status

Recruiting

Phase

Sponsor

Hospital St. Joseph, Marseille, France

Enrolment target

100

Start

04 Apr 2022

Estimated completion

01 Apr 2028

Non Metastatic Colorectal Cancer

What is this study about?

This study is about a new test called Immunoscore® and how it might help people who have had surgery for bowel (colorectal) cancer that hasn't spread to other parts of the body. When cancer hasn't spread, doctors call it 'non-metastatic'. After surgery to remove the cancer, doctors want to know the chances of it coming back. This helps them decide if you need more treatment, like chemotherapy, to try and stop it from returning.

The Immunoscore® test looks at specific immune cells within your original cancer tissue. These immune cells are part of your body's natural defense system. The test gives a 'score' based on how many of these cells are present and where they are located. Scientists believe this score might give an idea of how strong your body's fight against the cancer was, and therefore, how likely the cancer is to come back.

In this study, doctors are evaluating whether the results from this Immunoscore® test can help them make more informed decisions about your care. Specifically, they want to see if the test helps them recommend the right post-operative treatment (like chemotherapy) for each patient. The aim is to make sure you get the best possible care tailored to your individual situation, potentially avoiding unnecessary treatments for some, and ensuring others get the treatment they need.

Key takeaways

New study on bowel (colorectal) cancer that hasn't spread.
Investigating a test called Immunoscore® to predict cancer recurrence.
Aims to help doctors make better treatment choices after surgery.
Uses existing tissue samples and medical records.
No extra tests or changes to your current medical treatment.
Contributes to understanding personalised cancer care for the future.

Who may be eligible?

This study is looking for adults aged between 18 and 80 years old who have been diagnosed with bowel cancer that has not spread to other parts of the body. You must have had surgery to remove the cancer, and your doctors must have confirmed it was an adenocarcinoma, which is a common type of bowel cancer. Importantly, your cancer would have been classified as stage I, II, or III, meaning it was localised or had spread to nearby lymph nodes but not to distant organs.

You also need to be a candidate for chemotherapy treatment for six months after your surgery, even if you don't end up having it. You'll need to agree to let the researchers use a small piece of your removed cancer tissue for this study, and you must give your written permission to take part. You also need to be covered by a social security system.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you've had another type of cancer (apart from certain treated skin cancers or early cervical cancer) in the last three years. Also, if there are any reasons why you might not be able to fully understand or agree to take part, or if you have any conditions that would make it difficult to complete the study, you would be excluded.

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 between 18 and 80 years old?
Have you had surgery for bowel cancer that hadn't spread far?
Was your cancer confirmed as colon adenocarcinoma (a common type of bowel cancer)?
Are you able to agree to take part and provide written permission?
Do you not have another active cancer (except certain treated skin or cervical cancers)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

This study primarily involves reviewing your existing medical information and using a sample of the cancer tissue that was removed during your surgery. You won't actually receive the Immunoscore® test as part of the study; instead, a sample of your tumour will be sent for Immunoscore® analysis, and the study team will look at the results. The main focus is on seeing how doctors would change their treatment recommendations based on this test result.

You won't need extra hospital visits or assessments specifically for this study. You will continue to receive your usual medical care, and the study will collect information from your healthcare records. There are no new medications given as part of this research. The duration of your involvement will depend on how long doctors usually follow up on patients with your type of cancer, as the study team will be looking at your progress over time. For you, it will mostly involve your agreement for your medical data and tissue sample to be used.

Potential risks and benefits

Taking part in this study carries no direct risks to you, as it does not involve any changes to your treatment or any extra procedures. Your medical care will continue as normal. The main benefit for you individually isn't a direct health improvement, but rather the knowledge that you are contributing to a better understanding of bowel cancer. This research might help future patients and lead to more personalised and effective treatment decisions in the coming years. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Hôpital Européen
Verified postcode
Marseille, France· Not yet recruiting
Hopital Saint Joseph
Verified postcode
Marseille, France· Recruiting

Common questions

What is non-metastatic colorectal cancer?

It's bowel cancer that has not spread from where it started to other parts of the body, though it might have spread to nearby lymph nodes.

What is Immunoscore®?

It's a test that looks at certain immune cells inside your cancer tissue to understand your body's reaction to the cancer.

Will I get the Immunoscore® test myself?

No, a sample of your removed tumour tissue will be sent for the test, but you won't personally undergo a test as part of your care within this study.

Does this study involve new treatments?

No, this study is about how a test might help doctors decide on existing treatments, not about trialling new drugs.

Will my care change if I join this study?

No, your medical care will continue as usual. The study is observing how doctors might use the test results for future patient care.

How to find out more

Cécile BIELMANN

cbielmann@hopital-saint-joseph.fr 04 88 73 10 70 Official trial record

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