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

Acute Graft-versus-Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01521039
• Other study ID #: OSU-11002
• Status: Recruiting
• Start date: February 20, 2012
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Ohio State University Comprehensive Cancer Center
• Phone: 1-800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Graft-versus-Host Disease
• Allogeneic Stem Cell Transplant
• Graft vs Host Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlate miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with the severity of aGVHD.		up to 15 weeks
Secondary	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
Secondary	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

External Links

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