RecruitingOBSERVATIONAL

Trifecta-Lung cfDNA-MMDx Study

This research is looking for improved methods to detect if a transplanted lung is being rejected by the body. Currently, doctors often use a procedure called a transbronchial biopsy, but this can have downsides and sometimes results aren't clear. This study will explore a new, simpler blood test called dd-cfDNA, which measures tiny bits of DNA from the new lung in the patient's blood. Researchers want to see how well this blood test compares to a more advanced way of looking at biopsy samples, called the Molecular Microscope® (MMDx) system. By doing this, they hope to make it easier, safer, and more accurate to find out if a lung transplant patient is experiencing rejection, helping them get the right treatment sooner.

At a glance

Status

Recruiting

Sponsor

University of Alberta

Enrolment target

600

Start

01 Nov 2023

Estimated completion

01 Dec 2028

Lung Transplantation

What is this study about?

When someone has a lung transplant, it's really important for doctors to regularly check if their body is rejecting the new lung. Currently, this often involves a procedure where a small piece of the lung is taken for examination, called a biopsy. While helpful, these biopsies can sometimes be uncomfortable, and interpreting the results can be tricky, leading to disagreements among experts.

This study is trying to find better and more precise ways to check for rejection. It's looking at two main things. First, there's a new blood test that measures something called 'donor-derived cell-free DNA' (dd-cfDNA). This is like a tiny signature from the new lung circulating in your blood. If there's more of it, it might signal that the body is trying to reject the lung. The study wants to see how this new blood test lines up with another advanced testing method.

The second part of the study focuses on a special way of looking at biopsy samples, called the Molecular Microscope® (MMDx) system. This system uses cutting-edge technology to examine the genes in the lung tissue, providing a much clearer picture of what's happening at a cellular level. By comparing the results from the new dd-cfDNA blood test with the detailed MMDx results from biopsies, researchers hope to develop a more reliable and less invasive way to monitor lung transplant patients for rejection, ultimately helping them stay healthier longer.

Key takeaways

This study is looking for better ways to detect lung transplant rejection.
It compares a new blood test (dd-cfDNA) with advanced biopsy testing (MMDx).
The goal is to improve accuracy and potentially make monitoring safer.
Participants must be adult lung transplant recipients.
Participation involves giving blood samples and using existing biopsy samples; no extra invasive procedures for the study.
Results will help future patients, but won't change your current care.

Who may be eligible?

To be part of this study, you need to be an adult who has had a lung transplant. This includes people across all adult age groups.

However, some people won't be able to join. This includes if you don't want to take part or if you can't understand or agree to join the study yourself. Also, if you’ve received more than one organ transplant, have a current cancer diagnosis, or are pregnant, this study isn't suitable for you.

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 (18 years or older)?
Have you had a lung transplant?
Are you able to understand and agree to take part in the study?
Have you only had a lung transplant, not multiple organ transplants?
Do you currently not have cancer and are you not pregnant?

Answer every question to see your result.

What does participation involve?

Information about what taking part in this study involves wasn't fully detailed in the provided materials. However, generally, if you were to join, you would likely have additional blood tests to measure the dd-cfDNA levels. These blood tests would probably be timed to coincide with any existing biopsies you might already be having as part of your standard care, whether those are routine check-up biopsies or biopsies done because doctors suspect a problem. The study would use your existing biopsy samples for the MMDx testing. It's important to understand that no extra invasive procedures beyond your usual care would typically be required solely for this study. The total duration of your participation would depend on your care schedule.

Potential risks and benefits

Taking part in this study could potentially help doctors learn more about how to accurately detect lung transplant rejection, which could benefit future patients. For you personally, there is no direct medical benefit from participating, as the tests are for research and won't change your current care. The main procedures involve blood tests, which carry very minor risks like slight bruising or discomfort. Your biopsy samples will be used, but this is part of your standard care. Remember, joining a study is always voluntary, and you have the right to withdraw at any time without it affecting your medical care.

Locations (19)

St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT
Verified postcode
Phoenix, United States· Recruiting
Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida, College of Medicine
Verified postcode
Gainesville, United States· Recruiting
Mayo Clinic Florida, 4500 San Pablo Rd
Verified postcode
Jacksonville, United States· Recruiting
USF Health, Morsani College of Medicine, 12901 Bruce B. Downs Blvd. MDC40
Verified postcode
Tampa, United States· Recruiting
Indiana University Methodist Hospital 1812 N. Capitol Ave Suite W131L
Verified postcode
Indianapolis, United States· Recruiting
Johns Hopkins Interventional Pulmonology, Sheikh Zayed Tower, Room 7125L, 1800 Orleans Street
Verified postcode
Baltimore, United States· Recruiting
Division of Pulmonary, Allergy & Critical Care Medicine Columbia University Irving Medical Center
Verified postcode
New York, United States· Recruiting
The Ohio State University Wexner Medical Center, 410 W 10th Ave
Verified postcode
Columbus, United States· Recruiting
BAYLOR SCOTT & WHITE RESEARCH INSTITUTE , 3409 Worth Street
Verified postcode
Dallas, United States· Recruiting
UT Southwestern Medical Center, 5939 Harry Hines Blvd.
Verified postcode
Dallas, United States· Recruiting
Houston Methodist Lung Transplant Center, 6550 Fannin St., SM1001
Verified postcode
Houston, United States· Recruiting
UT Health San Antonio 7703 Floyd Curl Drive, MSC: 7858
Verified postcode
San Antonio, United States· Recruiting

Common questions

What is 'rejection' in a lung transplant?

Rejection is when your body's immune system tries to fight off the new lung, seeing it as foreign. This can damage the lung if not treated.

What is dd-cfDNA?

Dd-cfDNA stands for donor-derived cell-free DNA. These are tiny pieces of DNA from your new transplanted lung that circulate in your blood. Doctors think higher levels might indicate rejection.

What is MMDx?

MMDx (Molecular Microscope® Diagnostic System) is a special way of looking at biopsy samples using advanced technology to get a much more detailed picture of what's happening inside the lung tissue.

Will taking part in this study change my medical treatment?

No, this study is for research purposes. The results will not directly change your current medical treatment, but they will help doctors learn more for future patients.

Is a biopsy still needed if a blood test can check for rejection?

Currently, biopsies are the standard. This study is trying to see if the new blood test can work alongside or even potentially improve how we understand biopsy results, aiming for more accurate and possibly less invasive monitoring in the future.

How to find out more

Konrad S Famulski, PhD DSc

konrad@ualberta.ca 1 780 782 9463 Official trial record

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