Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)

Completed

• Conditions: Bone Marrow Transplantation

• Registration Number: NCT02081716
• Lead Sponsor: Asan Medical Center

Brief Summary

CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before and after bone marrow transplantation will further categorize the patients into high or low risk of CMV development after bone marrow transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in bone marrow transplant candidates to predict the development of CMV infection after transplantation.

Detailed Description

We will evaluate whether CMV-specific cell-mediated immune response before transplant, 1 month, 3 months, and 6 months after transplantation will predict CMV infection after bone marrow transplantation.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• age 16 or more
• agree with written informed consent

Exclusion Criteria

• no exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMV infection	6 months after transplantation	CMV infection is defined as follows.; 1. CMV viremia: CMV antigenemia or CMV quantitative PCR (+); 2. CMV disease: CMV syndrome or tissue-invasive CMV disease i) CMV syndrome: ① CMV viremia ② temperature \> 38 without other cause ③ WBC \< 4000, atypical lymphocyte \> 3%, transaminase elevation, platelet \< 100,000/mm ii) tissue-invasive CMV disease: evidence of CMV in histopathologic specimen (inclusion body or viral antigen in biopsy or bronchoalveolar lavage fluid)

Secondary Outcome Measures

Name	Time	Method
mortality	6 months after transplantation

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of