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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 29, 2014
Last verified: October 2014

January 23, 2012
October 29, 2014
February 2012
December 2015   (final data collection date for primary outcome measure)
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 ]
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. [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01521039 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Acute Graft-versus-Host Disease
  • Allogeneic Stem Cell Transplant
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
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.
Intervention: Procedure: Blood samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
United States
 
NCT01521039
OSU-11002
Yes
Yvonne Efebera, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Yvonne Efebera, MD Ohio State University
Ohio State University Comprehensive Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP