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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Graft-versus-Host Disease; Allogeneic Stem Cell Transplant
• Intervention / Treatment: Procedure: Blood samples

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 Type: Observational
• Enrollment (Anticipated): 270

Contacts and Locations

• Study Contact: Name: Ohio State University Comprehensive Cancer Center; Phone Number: 1-800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu
• Study Contact Backup: Name: Hannah Choe, MD; Email: Hannah.Choe@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Medical Center
      • Principal Investigator: Hannah Choe, MD
      • Contact: Hannah Choe, MD; Email: Hannah.Choe@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: peripheral blood; whole blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
Collect and store serum/plasma and mononuclear cells from patients receiving allogeneic blood and marrow stem cell transplantation.	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.	up to 14 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Hannah Choe, MD, Ohio State University

Publications and helpful links

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2012
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: aGVHD; Acute Graft-versus-Host Disease; allogeneic stem cell transplantation; Hematopoietic stem cell transplantation; MicroRNA Expression
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: OSU-11002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No