Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Yvonne Efebera, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01521039
First received: January 23, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).


Condition Intervention
Acute Graft-versus-Host Disease
Allogeneic Stem Cell Transplant
Procedure: Blood samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Measure miR-155 expression levels over time in the serum from patients receiving allogeneic stem cell transplant, and evaluate if miR-155 expression can predict development of aGVHD (Acute Graft-versus-Host Disease) [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with aGVHD diagnosis with matched allogeneic recipients without aGVHD. [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]
  • Correlate miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with the severity of aGVHD. [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Perform serum global microRNA analysis in allogeneic recipients at the time of clinical suspicion of aGVHD to identify other miRNAs that are associated with aGVHD diagnosis and severity. [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Collect and store serum/plasma and mononuclear cells from patients receiving allogeneic blood and marrow stem cell transplantation. [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]
    Perform the following: a) validation of the miRNA expression profiling signatures; b) correlation of miRNA expression among serum, plasma and mononuclear cells; and c) correlation of relevant miRNA targets or regulators expression (at the RNA or protein level) with miR-155 and other miRNAs expression identified in the aGVHD miRNA signatures.


Estimated Enrollment: 240
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Allogeneic SCT recipients
Patients who are receiving allogeneic stem cell transplantation at the Ohio State University are eligible and will be consented for the study.
Procedure: Blood samples
2-3 tablespoons of blood weekly for the first 100 days (about 14 weeks) following allogeneic transplant. In addition a blood sample will be obtained before starting the chemotherapy or radiation regimen for the transplant, in the day of the transplant and if your doctor suspects that you have acute graft-versus-host disease.
Other Names:
  • peripheral blood
  • whole blood

Detailed Description:

The purpose of this study is to examine whether the expression levels of a novel class of molecules, called microRNAs, are associated with acute graft-versus-host disease frequency and severity. Acute graft-versus-host disease is a Acute GVHD is a medical condition that can become very serious. It happens when the donor cells attack and damage your tissues after transplant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are receiving allogeneic stem cell transplantation at the Ohio State University are eligible and will be consented for the study.

Criteria

Inclusion Criteria:

  • Patients who are receiving allogeneic stem cell transplantation at the Ohio State University Blood and Marrow Transplantation program are eligible and will be consented for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521039

Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Yvonne Efebera, MD 614-293-2268 Yvonne.Efebera@osumc.edu

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Yvonne Efebera, MD    614-293-2268    Yvonne.Efebera@osumc.edu   
Contact: Ramiro Garzon, MD    6145-293-9868    Ramiro.garzon@osumc.edu   
Principal Investigator: Yvonne Efebera, MD         
Sub-Investigator: Ramiro Garzon, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Yvonne Efebera, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Yvonne Efebera, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01521039     History of Changes
Other Study ID Numbers: OSU-11002
Study First Received: January 23, 2012
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
aGVHD
Acute Graft-versus-Host Disease
allogeneic stem cell transplantation
Hematopoietic stem cell transplantation
MicroRNA Expression

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014