RECRUITING

A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy

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

This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly or bi-weekly. Study group assignment will take place at randomization. Subjects will be randomized 30 days (± 10 days) post-transplant to Prospera surveillance versus EMB surveillance in a 2:1 ratio. Rejection surveillance (Prospera Group and EMB Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.

Official Title

A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy (ACES-EMB)

Quick Facts

Study Start:2024-06-10
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06414603

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. Age 18 years or older at the time of signing informed consent.
  2. 2. Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.
  3. 3. Able to read, understand and provide written informed consent. If the patient is unable to sign informed consent, a legally authorized representative (LAR) can consent on behalf of the patient.
  4. 4. Able and willing to comply with the study visit schedule, study procedures and study requirements.
  1. 1. Concurrent multiple solid organ or tissue transplants.
  2. 2. Prior history of any organ or cellular transplantation.
  3. 3. Planned use of other commercially available or investigational cfDNA or gene expression profile assays for rejection surveillance.
  4. 4. Pregnant.
  5. 5. Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study.

Contacts and Locations

Study Contact

Kiara Stoddard
CONTACT
(650) 249-9090
ACES@natera.com

Principal Investigator

Michael Olymbios, MD
STUDY_DIRECTOR
Natera, Inc.
Josef Stehlik, MD
STUDY_CHAIR
University of Utah
Palak Shah, MD
STUDY_CHAIR
Inova Schar Heart and Vascular

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California, San Diego
San Diego, California, 92103
United States
University of Colorado
Aurora, Colorado, 80045
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Piedmont Healthcare
Atlanta, Georgia, 30309
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Duke University
Durham, North Carolina, 27710
United States
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Inova Schar Heart and Vascular Institute
Falls Church, Virginia, 22042
United States

Collaborators and Investigators

Sponsor: Natera, Inc.

  • Michael Olymbios, MD, STUDY_DIRECTOR, Natera, Inc.
  • Josef Stehlik, MD, STUDY_CHAIR, University of Utah
  • Palak Shah, MD, STUDY_CHAIR, Inova Schar Heart and Vascular

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 Date2024-06-10
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-06-10
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Heart Transplant

Additional Relevant MeSH Terms

  • Heart Transplant Failure and Rejection