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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01521039

Collaborator

(none)

Enrollment

Location

130.3

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Graft-versus-Host Disease Allogeneic Stem Cell Transplant	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 Design

Study Type:

Observational

Actual Enrollment :

22 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 20, 2012

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome 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) [up to 14 weeks]

Secondary Outcome 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. [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.