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

Completed

• Conditions: Allogeneic Stem Cell Transplant; Acute Graft-versus-Host Disease
• Interventions: Procedure: Blood samples

• Registration Number: NCT01521039
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-30
• Study Start: 2012-02-20
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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)	up to 14 weeks

Secondary Outcome Measures

Name	Time	Method
Collect and store serum/plasma and mononuclear cells from patients receiving allogeneic blood and marrow stem cell transplantation.	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.
Compare miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with aGVHD diagnosis with matched allogeneic recipients without aGVHD.	up to 14 weeks
Correlate miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with the severity of aGVHD.	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.	up to 15 weeks

Trial Locations

Locations (1)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States