RecruitingOBSERVATIONAL

Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients

This study aims to understand how a common melanoma treatment, anti-PD1 immunotherapy, changes the body's immune system. Melanoma is a type of skin cancer. While anti-PD1 treatment works well for many, it doesn't work for everyone, and some people experience side effects. Researchers will study immune cells in the blood of melanoma patients receiving this treatment. They hope to discover what makes some patients respond well and others less so, and to find ways to predict who will benefit most from treatment and who might experience fewer side effects. This information could lead to better, more personalised treatments in the future.

At a glance

Status

Recruiting

Sponsor

University Hospital, Grenoble

Enrolment target

707

Start

17 Jan 2024

Estimated completion

01 Jan 2031

Melanoma

What is this study about?

This research study is about understanding a specific type of cancer treatment called anti-PD1 immunotherapy, which is used for melanoma – a serious form of skin cancer. While this treatment is often very effective, it doesn't work for every patient, and some people might experience unwanted side effects. Researchers want to find out why this happens.

The main goal of this study is to look deeply at the immune system of people with melanoma who are receiving anti-PD1 therapy. Your immune system is your body's natural defense against illness. The researchers will be studying the different types of immune cells found in your blood to see how they change and react to the treatment. They will look at many features of these cells, such as their appearance, how they work, and what genes are active within them.

By doing this, the researchers hope to discover certain 'markers' in the blood before treatment even begins. These markers could help doctors predict which patients are most likely to respond well to anti-PD1 immunotherapy and which might need a different approach. Ultimately, this research aims to make cancer treatment more effective and personalised for each patient.

Key takeaways

The study investigates how anti-PD1 treatment affects immune cells in melanoma patients.
It aims to find clues (biomarkers) to predict who will respond best to treatment.
No new medications are given; it focuses on understanding existing treatments.
Findings could lead to more personalised and effective melanoma therapies in the future.
Participation involves providing consent and blood samples for analysis.

Who may be eligible?

To be considered for this study, you must have been diagnosed with melanoma, which has been confirmed by a doctor. This includes melanoma at various stages, from early to more advanced. You should also be able to understand and sign a consent form, agreeing to have your medical information used for this research.

There are certain reasons why you might not be able to join. For example, if you are under the care of a legal guardian or if your freedom is restricted, you cannot participate. The study also cannot include pregnant or breastfeeding women, children, or adults who have limited legal capacity or are hospitalised against their will.

Also, if you have a specific type of melanoma that affects the eye (called ocular melanoma), you would not be eligible for this particular study. The study is open to both men and women, aged 18 and over.

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.

Do I have a confirmed diagnosis of melanoma?
Am I 18 years old or older?
Am I able to understand and sign a consent form?
Am I NOT pregnant or breastfeeding?
Do I NOT have ocular (eye) melanoma?

Answer every question to see your result.

What does participation involve?

This study is mainly about collecting and examining blood samples to understand changes in immune cells. It does not involve taking new medication or undergoing new procedures beyond your standard melanoma treatment. You would be asked to provide blood samples, which would then be carefully analysed by the research team. The study involves looking at samples both retrospectively (from your past medical records with your consent) and prospectively (collecting new samples as you undergo treatment). The total duration of your involvement would depend on your course of standard treatment and follow-up, but it primarily involves providing consent for sample collection and analysis.

Potential risks and benefits

Participating in this study might not offer direct benefits to you personally, but the information gained could greatly help future melanoma patients by leading to more targeted and effective treatments. There are minimal risks, mainly associated with the blood draws, such as slight bruising or discomfort. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU Grenoble Alpes
Verified postcode
Grenoble, France· Recruiting

Common questions

What is anti-PD1 immunotherapy?

It's a type of cancer treatment that helps your own immune system fight melanoma cells more effectively.

Why are you studying immune cells?

By studying immune cells, researchers hope to understand why this treatment works for some people but not others, and how to make it better.

Will I receive new medicine as part of this study?

No, this study focuses on understanding the effects of your existing melanoma treatment, not on giving new medicines.

What is a 'biomarker'?

A biomarker is a natural signal in your body (like in your blood) that can give doctors information about your health or how you might respond to treatment.

Can I leave the study if I change my mind?

Yes, you can choose to withdraw from the study at any time, and this will not affect your medical care.

How to find out more

Julie Charles, MD, PhD

jcharles@chu-grenoble.fr 476769320 Official trial record

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