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

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ClinicalTrials.gov Identifier: NCT02081716
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Sung-Han Kim, 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.

Condition or disease
Bone Marrow 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 Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)
Study Start Date : March 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015


Group/Cohort
high CMV ELISPOT results
high spot counts in ELISPOT
low CMV ELISPOT results
low spot counts in ELISPOT



Primary Outcome Measures :
  1. CMV infection [ Time Frame: 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 :
  1. mortality [ Time Frame: 6 months after transplantation ]


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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
bone marrow transplant recipients
Criteria

Inclusion Criteria:

  • age 16 or more
  • agree with written informed consent

Exclusion Criteria:

  • no exclusion criteria

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): NCT02081716


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Sung-Han Kim, MD Asan Medical Center

Responsible Party: Sung-Han Kim, Assocaite Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02081716     History of Changes
Other Study ID Numbers: 2014-0103
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases