Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
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|ClinicalTrials.gov Identifier: NCT01521039|
Recruitment Status : Recruiting
First Posted : January 30, 2012
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment|
|Acute Graft-versus-Host Disease Allogeneic Stem Cell Transplant||Procedure: Blood samples|
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease|
|Actual Study Start Date :||February 13, 2012|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Collect and store serum/plasma and mononuclear cells from patients receiving allogeneic blood and marrow stem cell transplantation. [ Time Frame: up to 14 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521039
|Contact: Ohio State University Comprehensive Cancer Center||1-800-293-5066||OSUCCCClinicaltrials@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|
|Principal Investigator: Yvonne Efebera, MD|
|Principal Investigator:||Yvonne Efebera, MD||Ohio State University|