MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwell Health
- Locations
- 1
- Primary Endpoint
- Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
Time Frame: 24 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Cheryl Mensah
MD
Northwell Health