Thoracic Organ TransplantationNCT02423070
Genome Transplant Dynamics
An observational study of Thoracic Organ Transplantation, run by National Heart, Lung, and Blood Institute (NHLBI) at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Thoracic Organ Transplantation
- How many people
- 991 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Jun 2015to 30 Nov 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- -Pregnancy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 4 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21218
Steven Hsu, 410-955-3468, steven.hsu@jhmi.edu
Pali Shah, (410) 955-3468, pdedhiy2@jhmi.edu
- Terminated
University of Maryland
Baltimore, Maryland, 21228
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
- Recruiting
INOVA Fairfax Medical
Falls Church, Virginia, 22042
Palak Shah, M.D., 703-776-2213, palak.shah@inova.org
Steven Nathan, M.D., (703) 776-2213, steven.nathan@inova.org
- Recruiting
Dignity Health St. Joseph's Hospital and Medical Center Norton Thoracic Institut
Phoenix, Arizona, 85013
Sofya Tokman, M.D., 602-406-4000, sofya.tokman@commonspirit.org
- Active, not recruiting
Virginia Commonwealth University
Richmond, Virginia, 23284
- Completed
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read more
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.
Read the detailed description
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 donor-derived cell-free DNA (cfDNA) correlate with AR diagnosis and severity as detected by biopsy. The performance receiver operator curve (ROC) of cfDNA yielded an area under the curve (AUC) of 0.83. Using this technique, we can diagnose AR by measuring elevations in cfDNA up to 5 months before EMB-detected pathology. While these findings suggest that monitoring cfDNA 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 is 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 cfDNA for AR in a multicenter, prospective cohort study of heart and lung transplant patients, recruited through a consortium of transplant centers. The 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., chronic lung allograft dysfunction (CLAD) or chronic allograft vasculopathy (CAV). The exploratory objectives are: 1) to compare cfDNA characteristics in AMR (antibody-mediated rejection) and ACR (acute cellular rejection), 2) to study early immunological changes associated with a significant rise in cfDNA, and 3) to examine changes in microbiome architecture and other cell-free nucleic acids in rejection, 4) to determine if cfDNA trends correlate with treatment response for transplant complications, 5) to determine if the level of pre-transplant cfDNA identify patients at high risk of rejection post-transplant, 6) to determine genetic variants associated with post-transplant risk of rejection, high cfDNA levels and other complications.
- Conditions
- Thoracic Organ Transplantation
- Keywords
- Cell-free DNA, Acute Rejection, Thoracic Organ Transplantation, Non-Invasive Testing, Chronic Rejection, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Heart and Lung Transplant patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the time of biopsy-proven rejection
Secondary 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.
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start25 Jun 2015
- Primary completion30 Nov 2034 (estimated)
- Study completion30 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Thoracic Organ TransplantationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 991 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sean T Agbor-Enoh, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423070
- Sponsor's protocol ID
- 999915115
- Other IDs
- 15-H-N115
- Status last verified
- 17 Sep 2026
- First submitted
- 18 Apr 2015
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angelini A, Andersen CB, Bartoloni G, Black F, Bishop P, Doran H, Fedrigo M, Fries JW, Goddard M, Goebel H, Neil D, Leone O, Marzullo A, Ortmann M, Paraf F, Rotman S, Turhan N, Bruneval P, Frigo AC, Grigoletto F, Gasparetto A, Mencarelli R, Thiene G, Burke M. A web-based pilot study of inter-pathologist reproducibility using the ISHLT 2004 working formulation for biopsy diagnosis of cardiac allograft rejection: the European experience. J Heart Lung Transplant. 2011 Nov;30(11):1214-20. doi: 10.1016/j.healun.2011.05.011. Epub 2011 Aug 3.
PubMed 21816625De Vlaminck I, Khush KK, Strehl C, Kohli B, Luikart H, Neff NF, Okamoto J, Snyder TM, Cornfield DN, Nicolls MR, Weill D, Bernstein D, Valantine HA, Quake SR. Temporal response of the human virome to immunosuppression and antiviral therapy. Cell. 2013 Nov 21;155(5):1178-87. doi: 10.1016/j.cell.2013.10.034.
PubMed 24267896Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900. doi: 10.1056/NEJMoa0912965. Epub 2010 Apr 22.
PubMed 20413602Goldberg JF, Bagchi P, Mercado A, Shah KB, Najjar SS, Tchoukina I, Rodrigo ME, Hsu S, Jang M, Kong H, Marboe CC, Berry GJ, Valantine HA, Agbor-Enoh S, Shah P; GRAfT Investigators. Identification of Heart Transplant Rejection Subtypes With Circulating MicroRNAs. Circ Heart Fail. 2026 May;19(5):e013141. doi: 10.1161/CIRCHEARTFAILURE.124.013141. Epub 2026 Jan 12.
PubMed 41521923Alnababteh M, Keller MB, Kong H, Phipps K, Namian J, Ponor L, Shah P, Mathews J, Andargie T, Park W, Orens JB, Aryal S, Nathan SD, Bush E, Redekar N, Hill T, Jang M, Tian X, Agbor-Enoh S. Early post-transplant recipient tissue injury predicts allograft function, rejection and survival in lung transplant recipients: evidence from cell-free DNA. Eur Respir J. 2026 Apr 16;67(4):2402537. doi: 10.1183/13993003.02537-2024. Print 2026 Apr.
PubMed 40744691Shah P, Agbor-Enoh S, Lee S, Andargie TE, Sinha SS, Kong H, Henry L, Park W, McNair E, Tchoukina I, Shah KB, Najjar SS, Hsu S, Rodrigo ME, Jang MK, Marboe C, Berry GJ, Valantine HA; GRAfT Investigators. Racial Differences in Donor-Derived Cell-Free DNA and Mitochondrial DNA After Heart Transplantation, on Behalf of the GRAfT Investigators. Circ Heart Fail. 2024 Apr;17(4):e011160. doi: 10.1161/CIRCHEARTFAILURE.123.011160. Epub 2024 Feb 20.
PubMed 38375637Keller MB, Tian X, Jang MK, Meda R, Charya A, Berry GJ, Marboe CC, Kong H, Ponor IL, Aryal S, Orens JB, Shah PD, Nathan SD, Agbor-Enoh S. Higher Molecular Injury at Diagnosis of Acute Cellular Rejection Increases the Risk of Lung Allograft Failure: A Clinical Trial. Am J Respir Crit Care Med. 2024 May 15;209(10):1238-1245. doi: 10.1164/rccm.202305-0798OC.
PubMed 38190701Keller M, Bush E, Diamond JM, Shah P, Matthew J, Brown AW, Sun J, Timofte I, Kong H, Tunc I, Luikart H, Iacono A, Nathan SD, Khush KK, Orens J, Jang M, Agbor-Enoh S. Use of donor-derived-cell-free DNA as a marker of early allograft injury in primary graft dysfunction (PGD) to predict the risk of chronic lung allograft dysfunction (CLAD). J Heart Lung Transplant. 2021 Jun;40(6):488-493. doi: 10.1016/j.healun.2021.02.008. Epub 2021 Feb 20.
PubMed 33814284Agbor-Enoh S, Shah P, Tunc I, Hsu S, Russell S, Feller E, Shah K, Rodrigo ME, Najjar SS, Kong H, Pirooznia M, Fideli U, Bikineyeva A, Marishta A, Bhatti K, Yang Y, Mutebi C, Yu K, Kyoo Jang M, Marboe C, Berry GJ, Valantine HA; GRAfT Investigators. Cell-Free DNA to Detect Heart Allograft Acute Rejection. Circulation. 2021 Mar 23;143(12):1184-1197. doi: 10.1161/CIRCULATIONAHA.120.049098. Epub 2021 Jan 13.
PubMed 33435695Agbor-Enoh S, Chan JL, Singh A, Tunc I, Gorham S, Zhu J, Pirooznia M, Corcoran PC, Thomas ML, Lewis BGT, Jang MK, Ayares DL, Horvath KA, Mohiuddin MM, Valantine H. Circulating cell-free DNA as a biomarker of tissue injury: Assessment in a cardiac xenotransplantation model. J Heart Lung Transplant. 2018 Aug;37(8):967-975. doi: 10.1016/j.healun.2018.04.009. Epub 2018 Apr 26.
PubMed 29933912Agbor-Enoh S, Jackson AM, Tunc I, Berry GJ, Cochrane A, Grimm D, Davis A, Shah P, Brown AW, Wang Y, Timofte I, Shah P, Gorham S, Wylie J, Goodwin N, Jang MK, Marishta A, Bhatti K, Fideli U, Yang Y, Luikart H, Cao Z, Pirooznia M, Zhu J, Marboe C, Iacono A, Nathan SD, Orens J, Valantine HA, Khush K. Late manifestation of alloantibody-associated injury and clinical pulmonary antibody-mediated rejection: Evidence from cell-free DNA analysis. J Heart Lung Transplant. 2018 Jul;37(7):925-932. doi: 10.1016/j.healun.2018.01.1305. Epub 2018 Jan 31.
PubMed 29500138
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome Transplant Dynamics
- ClinicalTrials.gov ID
- NCT02423070
- Acronym / sponsor ID
- 999915115
- Conditions
- Thoracic Organ Transplantation
- Keywords
- Cell-free DNA, Acute Rejection, Thoracic Organ Transplantation, Non-Invasive Testing, Chronic Rejection, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 991 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 30 Nov 2034 (estimated)
- Study completion
- 30 Nov 2034 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 donor-derived cell-free DNA (cfDNA) correlate with AR diagnosis and severity as detected by biopsy. The performance receiver operator curve (ROC) of cfDNA yielded an area under the curve (AUC) of 0.83. Using this technique, we can diagnose AR by measuring elevations in cfDNA up to 5 months before EMB-detected pathology. While these findings suggest that monitoring cfDNA 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 is 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 cfDNA for AR in a multicenter, prospective cohort study of heart and lung transplant patients, recruited through a consortium of transplant centers. The 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., chronic lung allograft dysfunction (CLAD) or chronic allograft vasculopathy (CAV). The exploratory objectives are: 1) to compare cfDNA characteristics in AMR (antibody-mediated rejection) and ACR (acute cellular rejection), 2) to study early immunological changes associated with a significant rise in cfDNA, and 3) to examine changes in microbiome architecture and other cell-free nucleic acids in rejection, 4) to determine if cfDNA trends correlate with treatment response for transplant complications, 5) to determine if the level of pre-transplant cfDNA identify patients at high risk of rejection post-transplant, 6) to determine genetic variants associated with post-transplant risk of rejection, high cfDNA levels and other complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Heart and Lung Transplant patients |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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...
Time frame: At the time of biopsy-proven rejection
Fold change in cfDNA at the time of biopsy-proven rejection
1 secondary outcome
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).
Time frame: End of Study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 21816625Angelini A, Andersen CB, Bartoloni G, Black F, Bishop P, Doran H, Fedrigo M, Fries JW, Goddard M, Goebel H, Neil D, Leone O, Marzullo A, Ortmann M, Paraf F, Rotman S, Turhan N, Bruneval P, Frigo AC, Grigoletto F, Gasparetto A, Mencarelli R, Thiene G, Burke M. A web-based pilot study of inter-pathologist reproducibility using the ISHLT 2004 working formulation for biopsy diagnosis of cardiac allograft rejection: the European experience. J Heart Lung Transplant. 2011 Nov;30(11):1214-20. doi: 10.1016/j.healun.2011.05.011. Epub 2011 Aug 3.
- Background: PubMed 24267896De Vlaminck I, Khush KK, Strehl C, Kohli B, Luikart H, Neff NF, Okamoto J, Snyder TM, Cornfield DN, Nicolls MR, Weill D, Bernstein D, Valantine HA, Quake SR. Temporal response of the human virome to immunosuppression and antiviral therapy. Cell. 2013 Nov 21;155(5):1178-87. doi: 10.1016/j.cell.2013.10.034.
- Background: PubMed 20413602Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900. doi: 10.1056/NEJMoa0912965. Epub 2010 Apr 22.
- Derived from this study: PubMed 41521923Goldberg JF, Bagchi P, Mercado A, Shah KB, Najjar SS, Tchoukina I, Rodrigo ME, Hsu S, Jang M, Kong H, Marboe CC, Berry GJ, Valantine HA, Agbor-Enoh S, Shah P; GRAfT Investigators. Identification of Heart Transplant Rejection Subtypes With Circulating MicroRNAs. Circ Heart Fail. 2026 May;19(5):e013141. doi: 10.1161/CIRCHEARTFAILURE.124.013141. Epub 2026 Jan 12.
- Derived from this study: PubMed 40744691Alnababteh M, Keller MB, Kong H, Phipps K, Namian J, Ponor L, Shah P, Mathews J, Andargie T, Park W, Orens JB, Aryal S, Nathan SD, Bush E, Redekar N, Hill T, Jang M, Tian X, Agbor-Enoh S. Early post-transplant recipient tissue injury predicts allograft function, rejection and survival in lung transplant recipients: evidence from cell-free DNA. Eur Respir J. 2026 Apr 16;67(4):2402537. doi: 10.1183/13993003.02537-2024. Print 2026 Apr.
- Derived from this study: PubMed 38375637Shah P, Agbor-Enoh S, Lee S, Andargie TE, Sinha SS, Kong H, Henry L, Park W, McNair E, Tchoukina I, Shah KB, Najjar SS, Hsu S, Rodrigo ME, Jang MK, Marboe C, Berry GJ, Valantine HA; GRAfT Investigators. Racial Differences in Donor-Derived Cell-Free DNA and Mitochondrial DNA After Heart Transplantation, on Behalf of the GRAfT Investigators. Circ Heart Fail. 2024 Apr;17(4):e011160. doi: 10.1161/CIRCHEARTFAILURE.123.011160. Epub 2024 Feb 20.
- Derived from this study: PubMed 38190701Keller MB, Tian X, Jang MK, Meda R, Charya A, Berry GJ, Marboe CC, Kong H, Ponor IL, Aryal S, Orens JB, Shah PD, Nathan SD, Agbor-Enoh S. Higher Molecular Injury at Diagnosis of Acute Cellular Rejection Increases the Risk of Lung Allograft Failure: A Clinical Trial. Am J Respir Crit Care Med. 2024 May 15;209(10):1238-1245. doi: 10.1164/rccm.202305-0798OC.
- Derived from this study: PubMed 33814284Keller M, Bush E, Diamond JM, Shah P, Matthew J, Brown AW, Sun J, Timofte I, Kong H, Tunc I, Luikart H, Iacono A, Nathan SD, Khush KK, Orens J, Jang M, Agbor-Enoh S. Use of donor-derived-cell-free DNA as a marker of early allograft injury in primary graft dysfunction (PGD) to predict the risk of chronic lung allograft dysfunction (CLAD). J Heart Lung Transplant. 2021 Jun;40(6):488-493. doi: 10.1016/j.healun.2021.02.008. Epub 2021 Feb 20.
- Derived from this study: PubMed 33435695Agbor-Enoh S, Shah P, Tunc I, Hsu S, Russell S, Feller E, Shah K, Rodrigo ME, Najjar SS, Kong H, Pirooznia M, Fideli U, Bikineyeva A, Marishta A, Bhatti K, Yang Y, Mutebi C, Yu K, Kyoo Jang M, Marboe C, Berry GJ, Valantine HA; GRAfT Investigators. Cell-Free DNA to Detect Heart Allograft Acute Rejection. Circulation. 2021 Mar 23;143(12):1184-1197. doi: 10.1161/CIRCULATIONAHA.120.049098. Epub 2021 Jan 13.
- Derived from this study: PubMed 29933912Agbor-Enoh S, Chan JL, Singh A, Tunc I, Gorham S, Zhu J, Pirooznia M, Corcoran PC, Thomas ML, Lewis BGT, Jang MK, Ayares DL, Horvath KA, Mohiuddin MM, Valantine H. Circulating cell-free DNA as a biomarker of tissue injury: Assessment in a cardiac xenotransplantation model. J Heart Lung Transplant. 2018 Aug;37(8):967-975. doi: 10.1016/j.healun.2018.04.009. Epub 2018 Apr 26.
- Derived from this study: PubMed 29500138Agbor-Enoh S, Jackson AM, Tunc I, Berry GJ, Cochrane A, Grimm D, Davis A, Shah P, Brown AW, Wang Y, Timofte I, Shah P, Gorham S, Wylie J, Goodwin N, Jang MK, Marishta A, Bhatti K, Fideli U, Yang Y, Luikart H, Cao Z, Pirooznia M, Zhu J, Marboe C, Iacono A, Nathan SD, Orens J, Valantine HA, Khush K. Late manifestation of alloantibody-associated injury and clinical pulmonary antibody-mediated rejection: Evidence from cell-free DNA analysis. J Heart Lung Transplant. 2018 Jul;37(7):925-932. doi: 10.1016/j.healun.2018.01.1305. Epub 2018 Jan 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean T Agbor-Enoh, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Organ Transplantation, run by National Heart, Lung, and Blood Institute (NHLBI) at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean T Agbor-Enoh, M.D. ((703) 677-4630, agborenohst@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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... (time frame: At the time of biopsy-proven rejection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423070, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.