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Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
NCT07060716 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST donor-derived cell-free DNA test
Study Locations (10)
Florida
- Mayo Clinic in Florida — Jacksonville
- Tampa General Hospital — Tampa
California
- University of Southern California Keck School of Medicine — Los Angeles
Ohio
- Cleveland Clinic — Cleveland
Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh
Tennessee
- Vanderbilt University Medical Center — Nashville
Texas
- Baylor, Scott & White Research Institute — Dallas
Utah
- Intermountain Health — Murray
Baden-Wurttemberg
- Institute of Immunology - Transplantation Immunology — Heidelberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2025-09-08 |
| Est. Completion | 2025-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07060716
The ClinicalTrials.gov registry entry for NCT07060716 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insight Molecular Diagnostics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Kidney Transplant Rejection appearing as the primary indexed condition, and to 1 intervention — of which donor-derived cell-free DNA test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07060716 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07060716 about?
NCT07060716 is a clinical study titled "Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring". 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 detecte...
What is the current status of trial NCT07060716?
This trial is currently recruiting. The enrollment target is 125 participants. The study started on 2025-09-08. Estimated completion is 2025-12.
What conditions does trial NCT07060716 study?
This clinical trial studies the following conditions: Kidney Transplant Rejection, Cell-free DNA. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07060716?
The interventions under investigation include: donor-derived cell-free DNA test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07060716?
This trial is sponsored by Insight Molecular Diagnostics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07060716 being conducted?
This trial has 10 study locations across California, Florida, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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