NCT02917148

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 11, 2017

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 21, 2016

Last Update Submit

October 9, 2017

Conditions

Acute GVH Disease

Outcome Measures

Primary Outcomes (1)

  • Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.

    24 months

Study Arms (2)

aGVHD

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

non aGVHD

Patients who undergo allogeneic transplant but do not develop aGVHD.

Interventions

Peripheral Venipuncture or Blood draw from Central LineOTHER
Also known as: Venipuncture, Blood Draw
aGVHD

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients who receive transplants from incompletely matched donors
  • Patients who receive T cell depleted transplants
  • Patients who receive haplo-identical transplants
  • Pregnant Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monter Cancer Center

Lake Success, New York, 11042, United States

Location

Related 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.

    PMID: 19282026RESULT

  • 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.

    PMID: 23165480RESULT

  • 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.

    PMID: 24041574RESULT

  • 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.

    PMID: 24494749RESULT

Biospecimen

Retention: SAMPLES WITH DNA

This blood will be collected in lavender top, EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis. Plasma and serum samples from all patients will be frozen at -20 o C immediately after collection. RNAs will be extracted from plasma using Ambion RecoverAll kits, according to the directions provided by the manufacturer. Quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) will be performed on the samples as well. 754 microRNAs will be tested using ABI OpenArray platform.

MeSH Terms

Interventions

PhlebotomyBlood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Cheryl Mensah, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

October 11, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)