RecruitingNAINTERVENTIONAL

MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy

This study, called MORPHEE, aims to understand in detail how a special treatment, extracorporeal photochemotherapy (ECP), works. ECP is used for conditions like a type of skin cancer called cutaneous T-cell lymphoma, when a transplanted organ is rejected, and a complication of bone marrow transplants called graft-versus-host disease. Researchers want to find out how ECP causes cells to die and how this helps the body. By understanding these processes better, doctors hope to improve how ECP is used for different diseases. This is a research study looking at samples from adult patients already receiving ECP.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

Start

15 Apr 2022

Estimated completion

01 Jul 2025

Cutaneous T-Cell Lymphoma Graft Vs Host Disease Graft Rejection

What is this study about?

This study, called MORPHEE, is looking into how a treatment called extracorporeal photochemotherapy, or ECP, works at a very basic level. ECP is a treatment used for several serious conditions, including a type of skin cancer called cutaneous T-cell lymphoma, situations where the body might reject a transplanted organ (like a heart, lung, or kidney), and a complication after bone marrow transplants called graft-versus-host disease (GVHD). GVHD happens when new immune cells from a donor attack the patient's own body.

The main goal of this research is to understand exactly how ECP causes certain cells to die, and how this helps the body's immune system. Researchers believe that by understanding these changes in cells, they can learn how ECP calms down an overactive immune system, helps prevent organ rejection, or even fights cancer cells. Right now, we don't fully understand all the steps involved, which makes it harder for doctors to decide the best way to use ECP for each patient.

Taking part in this study would involve collecting samples from adult patients who are already receiving ECP for one of these conditions. The research team will then study these samples using various lab tests to look at how cells are affected by ECP. This knowledge will help doctors fine-tune ECP treatments in the future, making them more effective and tailored to individual patient needs. It's important to know that this study is about understanding the treatment better, not about testing a new treatment.

Key takeaways

This study aims to understand how ECP treatment affects cells.
It focuses on patients already receiving ECP for specific conditions like skin lymphoma, transplant rejection, or GVHD.
Participation involves providing samples during routine ECP sessions.
There are no new treatments or procedures for participants.
The findings could help improve ECP treatments for future patients.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be able to take part in this study, you need to be an adult patient, aged between 18 and 85 years old. You must already be receiving the ECP treatment for at least one month for one of these specific reasons: to manage graft-versus-host disease after a stem cell transplant, to treat or control organ rejection after a heart, lung, or kidney transplant, or to treat cutaneous T-cell lymphoma.

There are some reasons why you might not be able to join. For example, if you are pregnant, or if you have any condition that would prevent you from understanding and following the study's requirements. Also, if you are already involved in another clinical study that would stop you from taking part in this one, you wouldn't be eligible. The study is open to both men and women.

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 an adult between 18 and 85 years old?
Are you currently receiving ECP treatment (for at least one month)?
Is your ECP for cutaneous T-cell lymphoma, transplant rejection, or graft-versus-host disease?
Are you able to understand and follow study instructions?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

This study is focused on understanding how ECP works by studying samples. If you meet the criteria and choose to participate, you will not have to undergo any additional treatments or procedures beyond what you are already receiving as part of your standard ECP care. Your involvement will primarily consist of allowing researchers to collect samples (likely blood samples) during your routine ECP sessions. These samples will be analysed by the research team. The study doesn't involve any new medications, changes to your current ECP treatment, or extra follow-up visits. The total duration of your participation will depend on how long you are already receiving ECP and when the samples are collected; it will not extend beyond your existing treatment plan.

Potential risks and benefits

The potential benefits of taking part in this study are indirect. Your contribution will help doctors and researchers gain a better understanding of how ECP works, which could lead to improved treatments for future patients with similar conditions. There are minimal additional risks to you because the study primarily involves collecting samples during already planned medical procedures. Any risks associated with the ECP treatment itself are part of your standard care, not this study. You are free to withdraw from the study at any time without affecting your ongoing medical care.

Locations (1)

Centre Hospitalier Universitaire de Besançon
Verified postcode
Besançon, France· Recruiting

Common questions

What is ECP?

ECP stands for Extracorporeal Photochemotherapy. It's a treatment where some of your white blood cells are taken out, treated with medicine and light, and then put back into your body. It helps with certain immune conditions and cancers.

What is this study trying to find out?

This study is trying to understand, in detail, how ECP causes cells to die and how this helps treat conditions like skin lymphoma, transplant rejection, and graft-versus-host disease.

Do I have to do anything extra if I join?

No, this study only involves collecting samples during your routine ECP treatment. You won't have any extra appointments, treatments, or medication changes because of this study.

How long will I be in the study?

Your participation will be for the period when samples are collected, which will be within the timeframe of your existing ECP treatment. It won't extend your overall treatment duration.

Will this study change my treatment?

No, this study is observational, meaning it's about understanding how ECP works, not changing how you receive it. Your ECP treatment will continue as planned by your doctors.

How to find out more

Charline VAUCHY, PhD

cvauchy@chu-besancon.fr +33381218875 Official trial record

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