Genome Transplant Dynamics
ConditionThoracic Organ Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-80
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
About this trial
Study Description:
Heart and lung transplants can save lives, but long-term success is often limited by organ rejection that is hard to detect early. This study is testing a new, non-invasive blood test that looks for small pieces of DNA from the donor organ in the patient s blood. We believe higher levels of this donor DNA may signal early rejection before damage becomes permanent.
Hypothesis:
We believe that measuring donor-derived DNA in the blood can help detect early signs of rejection and improve outcomes for transplant patients.
The study also collects genetic and biological samples to explore why some people are more at risk of complications after transplant. This may help guide future research and treatments.
Who Can Join the Study:
People receiving a heart or lung transplant (or both), age 14 and older
People who are within three months of their transplant
People who can understand and agree to take part in the study
Participants will be asked to provide blood and other samples, and some of these will be used in lab research to explore new ideas about how and why transplant rejection happens.
This research could lead to better ways to monitor and treat patients after a heart or lung transplant - and help improve long-term survival and quality of life....
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Lung and heart transplant candidates. Dual organ transplants such as those that include lung or heart PLUS any other organ are also considered for enrollment.
Subjects who have undergone lung or heart transplants and are within 3 months of transplantation.
14 years and older
Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent.
Disqualifiers
None
Trial population
Lung and heart transplant candidates. Dual organ transplants such as those that include lung or heart PLUS any other organ are also considered for enrollment. -Subjects who have undergone lung or heart transplants and are within 3 months of transplantation. -14 years and older- Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent.- Retransplant candidates will be considered as a new transplants. These subjects will be approached for enrollment and if they consent to participate, they will be assigned a different SSPIN.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
991 Participants
are grouped into 1 trial groupGroup A: Cohort 1
Trial outcomes
Primary outcomes
1
To validate the predictive accuracy and ROC characteristics of circulating cell- free donor derived DNA (cfDNA) in multicenter, prospective cohort study of heart and lung transplant patients, recruited through a consortium of 5 transplant center...
Fold change in cfDNA at the time of biopsy-proven rejection
Time frame
At the time of biopsy-proven rejectionSecondary outcomes
1
To determine the association between early graft injury caused by acute rejection and infection and the development of chronic rejection, ie.,chronic lung allograft dysfunction (CLAD) or chronic allograft vasculopathy (CAV).
cfDNA in rejection grades 1R, 2R, and 3R, cfDNA at 1 month before biopsy diagnosis of AR, cfDNA after treatment of AR, cfDNA in ACR and AMR, spirometry grade of CLAD, angiographic grade of CAV, and number of AR per year, severity grade of clinically determined graft dysfunction, mean (cfDNA), all-cause mortality.
Time frame
End of StudySponsors and contacts
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Source ClinicalTrials.gov