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

NCT02109575 | Completed FDA Device

• 2 other identifiers: CHW 10/83R01HL119747
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Acute Rejection; Cardiac Biomarkers; Cardiac Catheterization; Cardiomyopathy; Cell-Free DNA; Congenital Heart Defect; Congenital Heart Disease; Coronary Angiogram; Donor Specific DNA; Donor Specific Cell-Free DNA; Endomyocardial Biopsy; Heart Failure; Heart Transplant Failure; Heart Transplant; Heart Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• Assay and laboratory protocol development and optimization.

  To develop and optimize an assay and protocol to detect donor-specific cell free DNA from recipient plasma.

  Year 1-5

Secondary Outcomes (1)

• Biomarker Development

  Year 1-3

Other Outcomes (1)

• Validation

  Years 4-5

Study Arms (1)

Heart Transplant Recipients

Up to 10 cc of blood will be drawn from heart transplant recipients at various time points prior to and after transplant. Blood draw is the only research activity that study participants will undergo. In addition to blood draw, data will be collected from clinical records representing the participant's transplant course such as the medical record, imaging, and biopsy slides with pathology reports.

Diagnostic Test: Blood Draw of up to 10 ml

Interventions

Blood Draw of up to 10 ml DIAGNOSTIC_TEST

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.

Heart Transplant Recipients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will include people of any age who have undergone heart transplant or who are "listed" to undergo heart transplant.

You may qualify if:

• Any patient who is "listed" to undergo or has in the past undergone heart transplantation.

You may not qualify if:

• Any patient who is not currently listed to undergo heart transplantation or has not previously received a heart transplant;
• Any patient who is not anticipated to be available for follow-up of at least 1 year;
• Any patient who is unable or unwilling to provide documented informed consent for self or through a legally authorized representative.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Columbia University: collaborator
• Duke University: collaborator
• Arkansas Children's Hospital Research Institute: collaborator
• Emory University: collaborator
• Children's Healthcare of Atlanta: collaborator
• Vanderbilt University: collaborator
• TAI Diagnostics, Inc.: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Children's Hospital and Health System Foundation, Wisconsin: collaborator
• University of California, Los Angeles: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Phoenix Children's Hospital: collaborator
• The Cleveland Clinic: collaborator

Study Sites (8)

Arkansas Children's Hosoptial Research Institute

Little Rock, Arkansas, 72202, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Ann & Robert H. Lurie Children's Hospital Chicago

Chicago, Illinois, 60611, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27711, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Cardiovascular Diseases; Rejection, Psychology; Cardiomyopathies; Heart Defects, Congenital; Heart Failure

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Heart Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Mitchell, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Aoy Tomita-Mitchell, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Cardiovascular Surgery

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2014
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

US (8)