RECRUITING

Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

Quick Facts

Study Start:2025-07-29
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07060716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is 18 years of age or older
  2. 2. At least 12 calendar days have elapsed since the subject received a kidney transplant.
  3. 3. Subject has provided legally effective informed consent
  4. 4. Subject agrees to comply with all study procedures
  1. 1. Kidney donor is an identical twin of the subject.
  2. 2. The subject has another previously transplanted organ in situ.
  3. 3. Subject has received a hematopoietic stem cell transplant.
  4. 4. Subject has received a bone marrow graft.
  5. 5. Subject has self-reported as pregnant.
  6. 6. In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.

Contacts and Locations

Study Contact

Robert Rogers, M.S.
CONTACT
14436258427
rrogers@imdxinc.com
Ekkehard Schuetz, MD, PhD
CONTACT
615-927-1528
eschuetz@imdxinc.com

Principal Investigator

Ekkehard Schuetz, MD, PhD
STUDY_CHAIR
Insight Molecular Diagnostics

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Intermountain Health
Murray, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Insight Molecular Diagnostics

  • Ekkehard Schuetz, MD, PhD, STUDY_CHAIR, Insight Molecular Diagnostics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-29
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-07-29
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Kidney Transplant Rejection
  • Cell-free DNA