Clinical trial NCT02917148: MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease
Official title: MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute GVH Disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients included in the study will be patients undergoing allogeneic transplantation, and some will suffer from aGVHD and some will not.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Monter Cancer Center
state: New York
Study officials:
affiliation: Northwell Health
name: Cheryl Mensah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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-2013-06-510586. Epub 2013 Sep 16.
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.