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

NCT01521039 | Completed

• 1 other identifier: OSU-11002
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Graft-versus-Host Disease; Allogeneic Stem Cell Transplant

Keywords

aGVHD; Acute Graft-versus-Host Disease; allogeneic stem cell transplantation; Hematopoietic stem cell transplantation; MicroRNA Expression

Outcome Measures

Primary Outcomes (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)

  up to 14 weeks

Secondary Outcomes (4)

• Compare miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with aGVHD diagnosis with matched allogeneic recipients without aGVHD.

  up to 14 weeks

• Correlate miR-155 expression at the time of clinical suspicion of aGVHD in allogeneic recipients with the severity of aGVHD.

  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.

  up to 15 weeks

• Collect and store serum/plasma and mononuclear cells from patients receiving allogeneic blood and marrow stem cell transplantation.

  up to 14 weeks

Study Arms (1)

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

Interventions

Blood samples PROCEDURE

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.

Also known as: peripheral blood, whole blood

Allogeneic SCT recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hannah Choe, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 30, 2012
• Study Start: February 20, 2012
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)