Targeted, Highly Sensitive, Non-Invasive Cardiac Transplant Rejection Monitoring

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medical College of Wisconsin
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT02109575
First received: February 10, 2014
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The investigator's primary goal is to quantitatively detect donor-specific DNA in plasma of organ transplant recipients. The investigator believe's that donor specific DNA can be isolated and quantified from transplant recipient serum. The investigator hypothesizes that the percent level of donor DNA circulating in recipient serum will reflect transplant rejection.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Highly Sensitive and Targeted Non-Invasive Test for the Surveillance of Rejection in Cardiac Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Percentage of Donor-Specific Cell-Free DNA in Plasma [ Time Frame: 1 to 5 years ] [ Designated as safety issue: No ]
    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. This aim will be ongoing throughout the multicenter study and the lab process is unblinded.


Secondary Outcome Measures:
  • Number of Circulating Donor-Specific Cell Free DNA [ Time Frame: 2 to 3 years ] [ Designated as safety issue: No ]
    To determine the threshold of elevation of circulating donor specific cell free DNA (cfDNA) and develop an accurate predictive model for cardiac allograft rejection. Clinical and demographic factors as well as quantification of donor specific and total cfDNA will contribute to the predictive model. This phase of the lab process is blinded.


Other Outcome Measures:
  • Measure true positive and true negative Donor Specific Cell Free DNA [ Time Frame: 4 to 5 years ] [ Designated as safety issue: No ]
    To validate the threshold and predictive model to evaluate sensitivity and specificity of donor specific cell free DNA to detect donor injury on a cellular level. This phase of the lab process is blinded.


Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 1000
Study Start Date: September 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study population will include patients of any age who have undergone cardiac transplant or who are listed to undergo cardiac transplant. Pediatric and adult heart transplant patients will be recruited from six cardiac transplant sites: Children's Hospital of Wisconsin, Arkansas Children's Hospital, Emory University, Duke Children's Hospital and Health Center, Columbia University Medical Center, and Vanderbilt University. The multicenter study will recruit up to 1,000 subjects over five years; of those, approximately 480 will be new transplant subjects. The multicenter study will expand a pilot study already implemented at Children's Hospital of Wisconsin. Children's Hospital of Wisconsin/Medical College of Wisconsin will serve as Coordinating Center for the Multicenter phase.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any patient who is not currently listed to undergo heart transplantation and has not previously received a heart transplant, or who is unable or unwilling to provide documented informed consent for self or through a legally authorized representative.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02109575

Contacts
Contact: Michael Mitchell, MD (414) 266-2491 mmitchell@chw.org
Contact: Anne Laulederkind, BSN (414) 805-8932 alaulede@mcw.edu

Locations
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael Mitchell, MD       mmitchell@chw.org   
Contact: Anne Laulederkind, BSN       alaulede@mcw.edu   
Principal Investigator: Michael Mitchell, MD         
Sub-Investigator: Mats Hidestrand, PhD         
Sub-Investigator: Steven Zangwill, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Michael Mitchell, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02109575     History of Changes
Other Study ID Numbers: CHW 10/83, R01HL119747
Study First Received: February 10, 2014
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Cardiac Biomarkers
Cardiac Catheterization
Congenital Heart Defect
Congenital Heart Disease
Coronary Angiogram
Heart Failure
Heart Transplant Failure
Heart Transplant
Heart Transplant Rejection
Acute Rejection
Cardiomyopathy
Cell-Free DNA
Donor Specific DNA
Donor Specific Cell-Free DNA
Endomyocardial Biopsy

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014