Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).
Acute Graft-versus-Host Disease
Allogeneic Stem Cell Transplant
Procedure: Blood samples
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease|
- 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 ]
- 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.
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521039
|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, 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.email@example.com|
|Principal Investigator: Yvonne Efebera, MD|
|Sub-Investigator: Ramiro Garzon, MD|
|Principal Investigator:||Yvonne Efebera, MD||Ohio State University|