MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease

Study Overview
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Brief Summary
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The goal of this research proposal is to identify a miRNA expression profile as a biomarker to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo allogeneic transplantation. This biomarker, once identified, will need validation in larger cohorts.

Detailed Description
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Human subjects that volunteer to participate in this study will be requested to have approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. These time intervals include prior to conditioning regimen for transplant, the day of transplantation, day +30, +60 and +100 after transplantation. If a given subject develops acute graft-versus-host disease, a blood sample will be obtained at that time as well. The amount of blood samples collected in an 8 week period will not exceed 50 ml and collection will not occur more than twice a week. There will be no pregnant women or children involved in the investigators study. All patients involved in the study will be undergoing bone marrow transplant and pregnancy screening is done in pre-transplant testing. This blood will be collected in lavender top, EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis.

Official Title
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MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease

Conditions
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Acute GVH Disease

Intervention / Treatment
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* Other: Peripheral Venipuncture or Blood draw from Central Line


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing fully matched allogeneic PBCSC and bone marrow transplantation who present with clinical signs and symptoms of grade II- IV aGVHD within 100 days after transplantation as defined by skin, GI, and/or liver involvement that are confirmed by biopsy, regardless of age Patients undergoing a matched, unrelated donor (8/8) or matched, related donor transplant (6/6) Allogeneic transplant is from donor's peripheral blood stem cells or bone marrow transplant Patients who develop grade II-IV aGVHD Exclusion Criteria: Patients who receive transplants from incompletely matched donors Patients who receive T cell depleted transplants Patients who receive haplo-identical transplants Pregnant Patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aGVHD<br>Patient who undergo allogeneic transplant with clinical and/or biopsy-proven diagnosis of aGVHD within the first 100 days post-transplant. | Other: Peripheral Venipuncture or Blood draw from Central Line<br> <br> * Other names: Blood Draw;|
| non aGVHD<br>Patients who undergo allogeneic transplant but do not develop aGVHD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls. |  | 24 months |