Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study)

Summary

The primary goal of this Multicenter Study is to develop and to evaluate a method for measuring donor-specific cell free DNA in blood samples from transplant recipients as markers of rejection. Blood samples obtained periodically from heart transplant recipients are assessed for cell free DNA relative to clinical data in order to determine whether changes in the level of cell free DNA indicate rejection.

This research study proposes testing a blood sample obtained from the heart transplant recipient. The research seeks to establish whether this blood test will show when the patient is beginning to or already rejecting the transplanted heart.

BACKGROUND Identifying if a transplant patient is beginning to or already rejecting the heart is necessary, so that appropriate treatment can be started to halt the rejection. Heart catheterization with biopsy is the usual method used for assessing whether a patient may be rejecting the heart. There are also a number of other methods that transplant physicians will use to look for signs of rejection including other blood tests, echocardiograms, obtaining pressure readings during heart catheterization, and micro-array testing of blood obtained during biopsy. These technologies are limited in ability to consistently and accurately identify the presence of rejection.

The usual method of checking for rejection involves obtaining a sample of the heart tissue (heart biopsy); biopsy can only be accomplished through heart catheterization which is an invasive procedure that has risks associated with disturbing the heart such as puncturing the heart or causing the heart rate to change or damaging tissue in the heart. Overtime, repeating this invasive procedure can diminish the ease of the procedure because the veins can become scarred and more difficult to access. For these reasons, researchers believe that it would be good to have a blood test that gives information about the possibility of rejection so that it may not be necessary to do as many heart biopsies. Also, a blood test may be able to provide information about the heart or about rejection that is currently not available at all.

Conditions

• Cardiovascular Disease
• Acute Rejection of Cardiac Transplant
• Cardiac Transplant Rejection
• Heart Transplant Failure and Rejection

Interventions

DIAGNOSTIC_TEST

Blood Draw of up to 10 ml

In a laboratory setting, the blood will be spun for plasma and buffy coat, DNA will be extracted for processing using the diagnostic test. The results of the test are not provided back to the clinical setting.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Columbia University

  collaborator OTHER

• Duke University

  collaborator OTHER

• Arkansas Children's Hospital Research Institute

  collaborator OTHER

• Emory University

  collaborator OTHER

• Children's Healthcare of Atlanta

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• TAI Diagnostics, Inc.

  collaborator INDUSTRY

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• Children's Hospital and Health System Foundation, Wisconsin

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Phoenix Children's Hospital

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Michael Mitchell, MD · Medical College of Wisconsin

• Aoy Tomita-Mitchell, PhD · Medical College of Wisconsin

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-01

Primary Completion

2020-03-30

Completion

2020-03-30

FDA Device

Yes

Countries

• United States

Study Locations