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

NCT02081716 | Completed

• 1 other identifier: 2014-0103
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Transplantation

Outcome Measures

Primary Outcomes (1)

• CMV infection

  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)

  6 months after transplantation

Secondary Outcomes (1)

• mortality

  6 months after transplantation

Study Arms (2)

high CMV ELISPOT results

high spot counts in ELISPOT

low CMV ELISPOT results

low spot counts in ELISPOT

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

bone marrow transplant recipients

You may qualify if:

• age 16 or more
• agree with written informed consent

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Study Officials

• Sung-Han Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

KR (1)