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

October 9, 2017 updated by: Cheryl Mensah, Northwell Health
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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
aGVHD
Patient who undergo allogeneic transplant with clinical and/or biopsy-proven diagnosis of aGVHD within the first 100 days post-transplant.
Other Names:
  • Venipuncture
  • Blood Draw
non aGVHD
Patients who undergo allogeneic transplant but do not develop aGVHD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cheryl Mensah, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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