Targeted, Highly Sensitive, Non-Invasive Cardiac Transplant Rejection Monitoring
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.
Acute Rejection of Cardiac Transplant
Cardiac Transplant Rejection
Heart Transplant Failure and Rejection
|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|
- 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.
- 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.
- 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
|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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02109575
|Contact: Michael Mitchell, MD||(414) email@example.com|
|Contact: Anne Laulederkind, BSN||(414) firstname.lastname@example.org|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Michael Mitchell, MD email@example.com|
|Contact: Anne Laulederkind, BSN firstname.lastname@example.org|
|Principal Investigator: Michael Mitchell, MD|
|Sub-Investigator: Mats Hidestrand, PhD|
|Sub-Investigator: Steven Zangwill, MD|
|Principal Investigator:||Michael Mitchell, MD||Medical College of Wisconsin|