Clinical Trial: MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease

Brief Summary: The goal of this research proposal is to identify a miRNA expression profile as a biomarker to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo allogeneic transplantation. This biomarker, once identified, will need validation in larger cohorts.

Detailed Summary:

Human subjects that volunteer to participate in this study will be requested to have approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. These time intervals include prior to conditioning regimen for transplant, the day of transplantation, day +30, +60 and +100 after transplantation. If a given subject develops acute graft-versus-host disease, a blood sample will be obtained at that time as well. The amount of blood samples collected in an 8 week period will not exceed 50 ml and collection will not occur more than twice a week. There will be no pregnant women or children involved in the investigators study.

All patients involved in the study will be undergoing bone marrow transplant and pregnancy screening is done in pre-transplant testing. This blood will be collected in lavender top, EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis.

Sponsor: Northwell Health

Current Primary Outcome: Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls. [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Northwell Health

Dates:
Date Received: September 21, 2016
Date Started: September 2016
Date Completion: September 2018
Last Updated: September 27, 2016
Last Verified: September 2016