GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
Insight Molecular Diagnostics
Summary
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit. Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is 18 years of age or older 2. At least 12 calendar days have elapsed since the subject received a kidney transplant. 3. Subject has provided legally effective informed consent 4. Subject agrees to comply with all study procedures Exclusion Criteria: 1. Kidney donor is an identical twin of the subject. 2. The subject has another previously transplanted organ in situ. 3. Subject has received a hematopoietic stem cell transplant. 4. Subject has received a bone marrow graft. 5. Subject has self-reported as pregnant. 6. In the opinion of the investigator, the subj…
Interventions
- Diagnostic Testdonor-derived cell-free DNA test
A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.
Locations (10)
- University of Southern California Keck School of MedicineLos Angeles, California
- Mayo Clinic in FloridaJacksonville, Florida
- Tampa General HospitalTampa, Florida
- Cleveland ClinicCleveland, Ohio
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Vanderbilt University Medical CenterNashville, Tennessee