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

Acute GVH Disease Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Acute GVH Disease
• Graft vs Host Disease

• NCT number: NCT02917148
• Study type: Observational
• Source: Northwell Health
• Status: Withdrawn
• Phase: N/A
• Start date: September 2016
• Completion date: September 2018