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

Completed

Conditions studied: Cardiac Transplant Rejection, Lung Transplant Rejection

In brief

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.

Key facts

Study ID

NCT01985412

Run by

Stanford University

People needed

65

Starts

2010-03-01

Expected to finish

2013-09-29

Last updated by the study team

2019-10-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All ages of heart or lung transplant recipients
• Recipients of re-do heart or re-do lung transplants

You may not qualify if…

• Patients wait-listed for multiple organ transplantation (e.g. heart-kidney, heart-liver, heart and lung.)
• Unable or unwilling to return to Stanford for biopsy and follow-up procedures
• 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)

Where it is running

• Kaiser Permanente Northern California — Santa Clara, California, United States
• Stanford University Hospital and Clinics — Stanford, California, United States

Full record on ClinicalTrials.gov

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