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

Study Overview
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Brief Summary
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Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).

Detailed Description
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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.

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

Conditions
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Acute Graft-versus-Host Disease, Allogeneic Stem Cell Transplant

Intervention / Treatment
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* Procedure: Blood samples


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Allogeneic SCT recipients<br>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<br>* 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.<br>* Other names: whole blood;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aGVHD, Acute Graft-versus-Host Disease, allogeneic stem cell transplantation, Hematopoietic stem cell transplantation, MicroRNA Expression