Genome Transplant Dynamics: Non-invasive Sequencing-based Diagnosis of Rejection

Trial ID or NCT#

NCT01985412,17540,26550

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to determine whether shotgun sequencing technology, which can be used to detect donor DNA in recipient plasma, can be used as a rapid, accurate, non-invasive method to detect Acute Cellular Rejection (ACR) after heart transplantation. Currently, all heart transplant recipients undergo invasive heart biopsies to diagnose ACR. Thus, there is an ongoing need to monitor patients for the development of acute and chronic rejection, with the primary goal of non-invasive early detection and treatment to prevent organ damage.

Official Title

Genome Transplant Dynamics: Non-Invasive Sequencing-Based Diagnosis of Rejection

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. All ages of heart or lung transplant recipients 2. Recipients of re-do heart or re-do lung transplants
Exclusion Criteria:
  1. 1. Patients wait-listed for multiple organ transplantation (e.g. heart-kidney, heart-liver, heart and lung.) 2. Unable or unwilling to return to Stanford for biopsy and follow-up procedures 3. Followed by Palo Alto VA Hospital after transplant surgery (VA patients are transplanted at Stanford, but all subsequent clinical care is performed at VA hospitals)

Investigator(s)

Hannah Valantine
Hannah Valantine
Cardiologist
Professor of Medicine (Cardiovascular)