RECRUITING

Trifecta-Heart cfDNA-MMDx Study

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Conditions

Heart Transplant RejectionDonor derived cfDNAgene expressionheart transplant biopsy

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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

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.

Official Title

Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test

Quick Facts

Study Start:2021-06-01
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04707872

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study.
  2. * Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent.
  1. * Patients will be excluded from the study if they decline participation
  2. * Are unable to give informed consent.
  3. * Recipients of multiple organs.

Contacts and Locations

Study Contact

Konrad Famulski, PhD
CONTACT
1 780 782 9463
konrad@ualberta.ca
Robert Polakowski, PhD
CONTACT
1 780 492 5091
polakows@ualberta.ca

Principal Investigator

Philip F Halloran, MD PhD
PRINCIPAL_INVESTIGATOR
Alberta Transplant Applied Genomics Center, University of Alberta

Study Locations (Sites)

Baptist Health Institute for Research and Innovation
Little Rock, Arkansas, 72205
United States
Columbia University Medical Center, Columbia Interventional Cardiovascular Care
W. New York, New Jersey, 10032
United States
Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL
Bronx, New York, 10467
United States
Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute
Dallas, Texas, 75246
United States
Cardiovascular Medicine, University of Utah Health
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: University of Alberta

  • Philip F Halloran, MD PhD, PRINCIPAL_INVESTIGATOR, Alberta Transplant Applied Genomics Center, University of Alberta

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 Date2021-06-01
Study Completion Date2027-07

Study Record Updates

Study Start Date2021-06-01
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Donor derived cfDNA
  • gene expression
  • heart transplant biopsy

Additional Relevant MeSH Terms

  • Heart Transplant Rejection