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

Withdrawn

• Conditions: Acute GVH Disease
• Interventions: Other: Peripheral Venipuncture or Blood draw from Central Line

• Registration Number: NCT02917148
• Lead Sponsor: Northwell Health

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 Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-11
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
aGVHD	Peripheral Venipuncture or Blood draw from Central Line	Patient who undergo allogeneic transplant with clinical and/or biopsy-proven diagnosis of aGVHD within the first 100 days post-transplant.

Primary Outcome Measures

Name	Time	Method
Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.	24 months

Trial Locations

Locations (1)

Monter Cancer Center; 🇺🇸 Lake Success, New York, United States