Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2023

Detailed Description

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.

Interventions

  • Procedure: Blood samples
    • 2-3 tablespoons of blood weekly for the first 100 days (about 14 weeks) following allogeneic transplant. In addition a blood sample will be obtained before starting the chemotherapy or radiation regimen for the transplant, in the day of the transplant and if your doctor suspects that you have acute graft-versus-host disease.

Arms, Groups and Cohorts

  • Allogeneic SCT recipients
    • Patients who are receiving allogeneic stem cell transplantation at the Ohio State University are eligible and will be consented for the study.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who are receiving allogeneic stem cell transplantation at the Ohio State University Blood and Marrow Transplantation program are eligible and will be consented for the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ohio State University Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hannah Choe, Principal Investigator – Ohio State University Comprehensive Cancer Center
  • Overall Official(s)
    • Hannah Choe, MD, Principal Investigator, Ohio State University
  • Overall Contact(s)
    • Ohio State University Comprehensive Cancer Center, 1-800-293-5066, OSUCCCClinicaltrials@osumc.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.