Clinical Trial: Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease

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

Official Title: Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease

Brief Summary: Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).

Detailed Summary: The purpose of this study is to examine whether the expression levels of a novel class of molecules, called microRNAs, are associated with acute graft-versus-host disease frequency and severity. Acute graft-versus-host disease is a Acute GVHD is a medical condition that can become very serious. It happens when the donor cells attack and damage your tissues after transplant.
Sponsor: Ohio State University Comprehensive Cancer Center

Current Primary Outcome: Measure miR-155 expression levels over time in the serum from patients receiving allogeneic stem cell transplant, and evaluate if miR-155 expression can predict development of aGVHD (Acute Graft-versus-Host Disease) [ Time Frame: up to 14 weeks ]

Original Primary Outcome: Measure miR-155 expression levels over time in the serum from patients receiving allogeneic stem cell transplant, and evaluate if miR-155 expression can predict development of aGVHD. [ Time Frame: up to 14 weeks ]

Current Secondary Outcome:

  • Compare miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with aGVHD diagnosis with matched allogeneic recipients without aGVHD. [ Time Frame: up to 14 weeks ]
  • Correlate miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with the severity of aGVHD. [ Time Frame: up to 15 weeks ]
  • Perform serum global microRNA analysis in allogeneic recipients at the time of clinical suspicion of aGVHD to identify other miRNAs that are associated with aGVHD diagnosis and severity. [ Time Frame: up to 15 weeks ]
  • Collect and store serum/plasma and mononuclear cells from patients receiving allogeneic blood and marrow stem cell transplantation. [ Time Frame: up to 14 weeks ]
    Perform the following: a) validation of the miRNA expression profiling signatures; b) correlation of miRNA expression among serum, plasma and mononuclear cells; and c) correlation of relevant miRNA targets or regulators expression (at the RNA or protein level) with miR-155 and other miRNAs expression identified in the aGVHD miRNA signatures.


Original Secondary Outcome: Same as current

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: January 23, 2012
Date Started: February 13, 2012
Date Completion: December 31, 2018
Last Updated: February 3, 2017
Last Verified: February 2017