RECRUITING

Genome Transplant Dynamics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

Genome Transplant Dynamics

Quick Facts

Study Start:2015-06-25
Study Completion:2034-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02423070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Subjects who have undergone lung or heart transplants and are within 3 months of transplantation.
  3. * 14 years and older
  4. * Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent.
  5. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sean T Agbor-Enoh, M.D.
CONTACT
(703) 677-4630
agborenohst@mail.nih.gov

Principal Investigator

Sean T Agbor-Enoh, M.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Johns Hopkins University
Baltimore, Maryland, 21218
United States
University of Maryland
Baltimore, Maryland, 21228
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
INOVA Fairfax Medical
Falls Church, Virginia, 22042
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • Sean T Agbor-Enoh, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-06-25
Study Completion Date2034-11-30

Study Record Updates

Study Start Date2015-06-25
Study Completion Date2034-11-30

Terms related to this study

Keywords Provided by Researchers

  • Cell-free DNA
  • Acute Rejection
  • Thoracic Organ Transplantation
  • Non-Invasive Testing
  • Chronic Rejection
  • Natural History

Additional Relevant MeSH Terms

  • Thoracic Organ Transplantation