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Trial record 1 of 1 for:    NCT01521039
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Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease

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ClinicalTrials.gov Identifier: NCT01521039
Recruitment Status : Active, not recruiting
First Posted : January 30, 2012
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Ayman Saad, Ohio State University Comprehensive Cancer Center

Study Description
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Brief Summary:
Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease (GVHD).

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

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.
Study Design
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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
Actual Study Start Date : February 20, 2012
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Ayman Saad, MD Ohio State University
More Information
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Additional Information:

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Responsible Party: Ayman Saad, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01521039    
Other Study ID Numbers: OSU-11002
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayman Saad, 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:
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Graft vs Host Disease
Immune System Diseases