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

Acute GVH Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02917148
• Other study ID #: 15-229
• Status: Withdrawn
• Phase: N/A
• First received: September 21, 2016
• Last updated: October 9, 2017
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute GVH Disease
• Graft vs Host Disease

Intervention

Other:
• Peripheral Venipuncture or Blood draw from Central Line

Locations

Country	Name	City	State
United States	Monter Cancer Center	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ferrara JL, Levine JE, Reddy P, Holler E. Graft-versus-host disease. Lancet. 2009 May 2;373(9674):1550-61. doi: 10.1016/S0140-6736(09)60237-3. Epub 2009 Mar 11. Review. — View Citation

Paczesny S. Discovery and validation of graft-versus-host disease biomarkers. Blood. 2013 Jan 24;121(4):585-94. doi: 10.1182/blood-2012-08-355990. Epub 2012 Nov 19. Review. — View Citation

Xiao B, Wang Y, Li W, Baker M, Guo J, Corbet K, Tsalik EL, Li QJ, Palmer SM, Woods CW, Li Z, Chao NJ, He YW. Plasma microRNA signature as a noninvasive biomarker for acute graft-versus-host disease. Blood. 2013 Nov 7;122(19):3365-75. doi: 10.1182/blood-20 — View Citation

Xie LN, Zhou F, Liu XM, Fang Y, Yu Z, Song NX, Kong FS. Serum microRNA155 is increased in patients with acute graft-versus-host disease. Clin Transplant. 2014 Mar;28(3):314-23. doi: 10.1111/ctr.12314. Epub 2014 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.		24 months