Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling
D-OAR
Utility of Donor-Derived Cell-free DNA in Association With Gene-Expression Profiling (AlloMap®) in Heart Transplant Recipients (D-OAR)
1 other identifier
observational
100
1 country
28
Brief Summary
Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedOctober 29, 2024
October 1, 2024
5.5 years
June 13, 2014
October 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Outcomes (Vital Status of Heart Transplant Recipients)
Graft dysfunction, Rejection with hemodynamic compromise: Hemodynamic compromise is defined by the presence of one or more of the following criteria: Proportional decrease in LVEF ≥ 25%, Absolute LVEF ≤ 30%, Need for inotropic support, Cardiac index \< 2.0 L/min/m2, Death (re-transplantation)
3 years
Study Arms (1)
Heart Transplant Recipients
Heart allograft recipients undergoing scheduled surveillance visits that are part of a long-term management plan.
Eligibility Criteria
Heart allograft recipients undergoing scheduled surveillance visits that are part of a long-term management plan.
You may qualify if:
- Any heart transplant recipient eligible for initiation and participation in the Outcomes AlloMap Registry (OAR) Study of regular AlloMap testing.
- Patients can be enrolled any time as long as they have not had more than 1 prior AlloMap.
You may not qualify if:
- \. Pregnant Women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CareDxlead
Study Sites (28)
Cedars-Sinai Medical Center
Beverly Hills, California, 90211, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Stanford University
Stanford, California, 94305, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
St. Vincent Medical Group
Indianapolis, Indiana, 46260, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mid America Heart Institute - St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Washington University
St Louis, Missouri, 63110, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor St. Lukes
Houston, Texas, 77030, United States
Intermountain Heart Institute
Murray, Utah, 84107, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (2)
Grskovic M, Hiller DJ, Eubank LA, Sninsky JJ, Christopherson C, Collins JP, Thompson K, Song M, Wang YS, Ross D, Nelles MJ, Yee JP, Wilber JC, Crespo-Leiro MG, Scott SL, Woodward RN. Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn. 2016 Nov;18(6):890-902. doi: 10.1016/j.jmoldx.2016.07.003. Epub 2016 Oct 7.
PMID: 27727019BACKGROUNDKobashigawa, JA. et al; Initial Analysis of the Donor-Derived Cell-Free DNA -Outcomes AlloMap Registry (D-OAR) Study in Heart Transplant Recipients Undergoing Surveillance for Rejection. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC
RESULT
Biospecimen
donor derived cf-DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James P Yee
CareDx Inc (formerly XDx Inc) Brisbane, CA
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
July 1, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2019
Study Completion
February 1, 2020
Last Updated
October 29, 2024
Record last verified: 2024-10