Active not recruitingOBSERVATIONAL

PREdiction of Chronic LUng Allograft Dysfunction

This study focuses on a serious problem called Chronic Lung Allograft Dysfunction (CLAD), which can happen after a lung transplant. CLAD is the main cause of long-term health issues and can sadly shorten lives. Currently, doctors often find out about CLAD quite late, when the new lung is already badly damaged and it's harder to treat. Researchers have found some clues in the blood that might help predict CLAD much earlier – possibly more than six months before symptoms even start. This study is taking these clues, along with other health information, to create a new, clearer way to predict who might develop CLAD. The goal is to develop a reliable test that helps doctors give patients the best chance of a healthy future with their new lungs.

At a glance

Status

Active not recruiting

Sponsor

Nantes University Hospital

Enrolment target

240

Start

10 Sep 2020

Estimated completion

01 Mar 2027

Lung Transplant Rejection

What is this study about?

After someone has a lung transplant, their new lung can sometimes start to have problems. One serious problem is called Chronic Lung Allograft Dysfunction (CLAD). This is the main reason why people unfortunately don't live as long as hoped after a transplant. Sadly, doctors often don't realise CLAD is happening until the new lung is already quite damaged, which makes it much harder to fix. Scientists have been trying to understand exactly why CLAD happens and what triggers it, as this isn't fully clear yet.

Researchers have found some useful signs in blood tests that might show if someone is at risk of CLAD, even many months before they show any symptoms. Think of it like a very early warning system. This study is taking these early warning signs, along with other health information from a large group of people who have had lung transplants, to create a new way to predict CLAD. They are aiming to develop a combined score – like putting different pieces of a puzzle together – that can reliably tell who might be at high risk.

The main goal of this project is to check if this new prediction method, or "score," really works and can accurately tell doctors who will likely develop CLAD. If it does, doctors could then use this information to give better and earlier care to patients, hopefully preventing the worst effects of CLAD and helping transplant patients live longer, healthier lives with their new lungs.

Key takeaways

CLAD is a major issue after lung transplants.
The study aims to predict CLAD much earlier using blood tests and patient data.
It's about creating a new, reliable prediction tool for doctors.
Better prediction means earlier, more effective treatment.
Participation helps future lung transplant patients.
You must be 16 or over and awaiting a lung transplant to join.

Who may be eligible?

This study is looking for people who are getting ready for a lung transplant and are waiting to be put on the transplant list. You need to be connected to the UK's social security system, like the NHS, and you must agree to take part, understanding what's involved. Also, you need to be at least 16 years old and weigh more than 26 kilograms (about 4 stone).

There are some reasons why you might not be able to join. If you are pregnant or breastfeeding, this study isn't for you. It's also not suitable if you have other ongoing inflammatory diseases that cause swelling and pain in your body, or if you've recently had cancer (less than 5 years ago). Very specific skin cancers are an exception, but not melanoma. Finally, you need to be able to stick to the study's plan and attend any appointments as required.

The study leaders want to make sure the results are helpful for the right people, so these rules help them find suitable participants. Always talk to your doctor or the study team if you're not sure if you qualify.

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 currently waiting for a lung transplant?
Are you 16 years old or older?
Do you weigh more than 26 kilograms?
Are you not pregnant or breastfeeding?
Do you not have active inflammatory diseases or recent cancer (within 5 years, excluding specific skin cancers)?
Are you able to follow the study instructions?

Answer every question to see your result.

What does participation involve?

The information provided does not detail the participation requirements, such as the number of visits, specific assessments, or the total duration of involvement. This is a study to develop and validate a predictive score, likely involving the collection and analysis of blood samples and clinical data from patients already undergoing standard care after lung transplantation. It's possible that participation might involve providing additional blood samples beyond routine care, or allowing researchers to access your medical records more extensively. However, without specific details, it's not possible to outline the exact commitment. You would normally be given a detailed participant information sheet that explains all visits, tests, and time commitments.

Potential risks and benefits

Taking part in research always has a balance of potential benefits and risks. For this study, potential benefits might include contributing to new knowledge that could significantly help future lung transplant patients. If the new prediction method works, it could lead to earlier treatment for others, improving their long-term health. However, direct personal benefits for you as a participant in developing the score are unlikely. Risks might include the discomfort of extra blood tests, if required, or the emotional impact of discussing your health in detail. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (10)

CHU de Bordeaux
Verified postcode
Bordeaux, France
CHU de Grenoble
Verified postcode
Grenoble, France
Centre Chirurgical Marie Lannelongue
Verified postcode
Le Plessis-Robinson, France
CHU de Lyon
Verified postcode
Lyon, France
AP-HM
Verified postcode
Marseille, France
CHU de Nantes
Verified postcode
Nantes, France
Hôpital Bichat
Verified postcode
Paris, France
CHRU de Strasbourg
Verified postcode
Strasbourg, France
Hôpital Foch
Verified postcode
Suresnes, France
CHU de Toulouse
Verified postcode
Toulouse, France

Common questions

What is CLAD?

CLAD stands for Chronic Lung Allograft Dysfunction. It's a serious, long-term problem that can happen to a new lung after a transplant, making it harder for the lung to work properly.

Why is this study important?

It's important because CLAD is the main reason why people have long-term problems after a lung transplant. This study hopes to find a way to predict it much earlier, so doctors can help patients sooner.

Will taking part benefit me directly?

It's unlikely to benefit you personally in the short term, but your involvement could help improve care for future lung transplant patients.

What does 'social security system' mean for me?

It generally means you are eligible for healthcare through the NHS, as this study is likely for UK residents.

Can I stop participating if I change my mind?

Yes, you can withdraw from the study at any time without giving a reason, and it won't affect your medical care.