Genome Transplant Dynamics

Age Range:18 - 80
Start Date:June 25, 2015
End Date:November 30, 2024
Contact:Sean T Agbor-Enoh, M.D.
Phone:(703) 677-4630

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- Some people with advanced heart and lung disease have heart and lung transplants. But the
organs are often rejected. When this happens, the organ recipients must have repeated
biopsies. These are invasive and expensive. Researchers want to see if a blood test can
predict rejection and take the place of biopsies. The test shows how much donor DNA is in a
recipient s blood.


- To see if a new blood test can be used instead of biopsies to diagnose rejection after


- Adults 18 years and older who are on the lung or heart transplant waitlist.


- Participants will have about 4 teaspoons of blood drawn from the arm before having their

- Researchers will collect demographic data about participants. They will also collect
basic medical information about their condition.

- After surgery, while still in the hospital, participants will have 2 teaspoons of blood
drawn twice a week until they go home.

- At each biopsy visit after the transplant, participants will have 4 teaspoons of blood
drawn for testing for up to 5 years.

Acute rejection (AR) occurs within the first 6 months after transplantation in 20 percent of
heart-transplant patients and in 50 percent of lung-transplant patients. Given the often
silent clinical presentation of AR, these patients require monitoring with repeated invasive
and costly endomyocardial (EMB) or transbronchial biopsies (TBBx). Since organ
transplantation is essentially genomic transplantation, our prior studies leveraged the use
of distinctive graft and recipient genotype single-nuclear polymorphisms (SNPs) to barcode
donor DNA circulating in recipient serum. We have shown that levels of donor DNA measured as
the percentage of circulating cell-free donor-derived DNA (%ccfdDNA) correlates with AR
diagnosis and severity as detected by biopsy. The performance receiver operator curve (ROC)
of %ccfdDNA yielded an area under the curve (AUC) of 0.83. Using this technique, we can
diagnose AR by measuring elevations in %ccfdDNA up to 5 months before EMB-detected pathology.
While these findings suggest that monitoring %ccfdDNA may offer a high-performing,
non-invasive, and early diagnostic tool of AR, further validation studies are required to
determine its clinical utility. The ability to diagnose AR earlier than possible with a
biopsy offers an opportunity to investigate the pathogenesis of rejection as well as to
identify potential AR biomarkers. Thus, the primary objective of this study is to validate
the predictive accuracy and ROC characteristics of %ccfdDNA for AR in a multicenter,
prospective cohort study of heart- and lung-transplant patients, recruited through a
consortium of 5 transplant centers in the Washington, DC metropolitan area. The major
secondary objective is to determine the association between early graft injury caused by
acute rejection and infection and the development of chronic rejection, i.e., bronchiolitis
obliterans syndrome (BOS) or chronic allograft vasculopathy (CAV). The exploratory secondary
objectives are: 1) to compare %ccfdDNA characteristics in AMR (antibody-mediated rejection)
and ACR (acute cellular rejection), 2) to study early immunological changes associated with a
significant rise in %ccfdDNA, and 3) to examine changes in microbiome architecture and other
cell-free nucleic acids in rejection.


- Lung and heart transplant candidates

- Subjects who have undergone lung or heart transplants within 3 months of

- 18 years and older

- Able to understand and willing to sign the informed consent form


We found this trial at
3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Phone: 703-776-3610
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
Falls Church, VA
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3400 N Charles St
Baltimore, Maryland 21205
Phone: 410-955-3468
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
Baltimore, MD
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Catonsville, Maryland 21228
Phone: 800-373-4111
Catonsville, MD
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Richmond, Virginia 23298
(804) 828-0100
Phone: 804-828-4527
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
Richmond, VA
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Washington, District of Columbia
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