RecruitingNAINTERVENTIONAL

Prospective Monocentric Study Evaluating the Circulating NK Cells Phenotype and the ImmunoScore® in Patients With Non Metastatic Rectal Cancer

This study is investigating new approaches for people with rectal cancer that hasn't spread to other parts of the body. Traditionally, treatment involved radiation and chemotherapy, but we're looking for better ways to predict how well a person will respond. Researchers want to use blood tests to study immune cells called 'Natural Killers' (NK cells) and a special 'ImmunoScore' test. The goal is to see if these tests can help us understand who might achieve a complete response to treatment, potentially allowing them to avoid surgery and improve their quality of life. This could lead to more tailored and less invasive treatment plans for future patients.

At a glance

Status

Recruiting

Phase

Sponsor

Institut Sainte Catherine

Enrolment target

100

Start

16 Jul 2024

Estimated completion

30 Jul 2028

Rectal Cancer Non Metastatic Cancer

What is this study about?

This research is all about helping people with rectal cancer that hasn't spread to other parts of the body. Currently, treatment often involves a combination of radiotherapy and chemotherapy. While this works for many, scientists are always looking for ways to make treatments even better and more personal. One exciting area is understanding how a person's own immune system fights cancer.

This study focuses on two main things: looking at specific immune cells called 'Natural Killer' (NK) cells in your blood and using a special test called 'ImmunoScore'. NK cells are part of your body's natural defence system, and scientists believe they play a big role in fighting cancer. The ImmunoScore is a way to measure certain immune cells directly within the tumour. By studying these, researchers hope to find out if they can predict how well someone will respond to treatment before, during, and after therapy. This could mean fewer side effects for patients and a better understanding of who might benefit from different treatment approaches.

The ultimate goal is to improve treatment for rectal cancer patients, especially by identifying those who might achieve such a good response to initial treatments that they could potentially avoid major surgery. Avoiding surgery can significantly improve a person's quality of life. This research aims to collect important information that could lead to new tests and better ways to decide on the best treatment plan for each individual patient.

Key takeaways

The study explores how immune cells and a test called ImmunoScore can predict rectal cancer treatment response.
It aims to improve patient quality of life by identifying who might avoid surgery.
Participation involves providing extra blood samples during your standard treatment.
Your standard cancer treatment will not be changed by taking part.
The findings could lead to more personalised and less invasive treatments for future patients.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with rectal cancer that hasn't spread to other parts of your body. Your doctors must have planned for you to receive a specific type of radiotherapy along with chemotherapy.

There are a few reasons you wouldn't be able to join. For example, if your cancer has already spread, or if you've already had radiotherapy in the same area. Also, if you have other serious medical conditions or issues that would make it hard for you to follow the study plan, you wouldn't be able to take part. Researchers want to make sure the study is safe and effective for everyone involved.

Women who could become pregnant must be using effective contraception. You'll also need to be part of a social security scheme and willingly sign a consent form showing you understand and agree to take part.

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 rectal cancer that hasn't spread?
Are you able to follow the study plan (e.g., attend appointments for blood tests)?
Are you receiving a specific type of radiotherapy and chemotherapy for your cancer?
If you're a woman who could get pregnant, are you using effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't be given any new drugs or treatments as part of this study. Your standard treatment for rectal cancer will continue as planned by your medical team. The main involvement for you will be providing extra blood samples at various points: before, during, and after your cancer treatment. These blood samples will be used to look at your immune cells and the ImmunoScore. The total duration of your participation will depend on your treatment plan and follow-up schedule, but it will involve these periodic blood tests. There are no extra visits to the hospital specifically for this study, as the blood samples will likely be taken during your regular clinic appointments.

Potential risks and benefits

Taking part in this study won't change your standard medical care, so there are no direct medical risks from the study itself beyond the usual risks associated with blood tests, such as minor bruising or discomfort. A potential benefit is that the information gathered from your samples could help future patients by leading to better ways of predicting how they will respond to treatment, and potentially helping them avoid surgery. However, there are no direct personal benefits to you from participating. You are free to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

ICAP
Verified postcode
Avignon, France· Recruiting

Common questions

What is 'non-metastatic rectal cancer'?

This means cancer in the rectum that hasn't spread to other parts of your body.

What are NK cells?

NK stands for 'Natural Killer' cells. They are a type of immune cell that helps your body fight off infections and cancer.

What is the 'ImmunoScore'?

It's a special test that measures how many and what types of immune cells are found directly within your tumour.

Will taking part change my cancer treatment?

No, your cancer treatment will remain exactly as your doctors have planned. This study mainly involves extra blood tests.

Why is avoiding surgery important?

Avoiding surgery can significantly improve a patient's quality of life, as surgery can have its own risks and recovery time.

How to find out more

Léa Retournard, MDV

l.retournard@isc84.org +33490276241 Official trial record

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