Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
This study is currently recruiting participants.
Verified January 2013 by Ohio State University Comprehensive Cancer Center
Sponsor:
Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
Yvonne Efebera, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01521039
First received: January 23, 2012
Last updated: February 6, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 23, 2012 | ||||||||
| Last Updated Date | February 6, 2013 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT01521039 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease | ||||||||
| Official Title ICMJE | Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease | ||||||||
| Brief Summary | Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD). |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | 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:
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| Study Group/Cohort (s) | 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 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 330 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01521039 | ||||||||
| Other Study ID Numbers ICMJE | OSU-11002 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Yvonne Efebera, Ohio State University Comprehensive Cancer Center | ||||||||
| Study Sponsor ICMJE | Ohio State University Comprehensive Cancer Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Ohio State University Comprehensive Cancer Center | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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