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Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00173264
Collaborator
(none)
30
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the monoclonal protein in patients with tuberculosis and monoclonal gammopathy has anti-tuberculous activity, and whether genes coding their monoclonal proteins show characteristic mutations.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Monoclonal immunoglobulins arise from abnormal proliferation of a single clone of plasma cells. They are composed of a single light and/or heavy chain class, in contrast to polyclonal immunoglobulins. They may occur in malignant lymphoproliferative diseases, such as multiple myeloma, Waldenstrom's macroglobulinemia, lymphoma, chronic lymphocytic leukemia, amyloidosis, or more benign conditions such as monoclonal gammopathy of undetermined significance (MGUS). Recently we have observed monoclonal gammopathy occurring in patients with tuberculosis. Whether tuberculous infection plays a role in the production of monoclonal protein, and whether the monoclonal immunoglobulins possess anti-tuberculous activity are unknown. In the current project we plan to study: (1) whether the monoclonal immunoglobulin developed in patients with tuberculosis reacts with tuberculous antigen (using ELISA), and (2) whether the VH gene sequence analysis of such patient shows different mutation patterns (indicating the presence of intraclonal mutation variation) or not. If there is no intraclonal mutation variation, it suggests that the plasma cell clone is not under current exposure to the mutator, and the production of monoclonal gammopathy is probably not related to tuberculous infection. If, however, the VH gene sequence analysis shows the presence of intraclonal mutation variation, it indicates that the plasma cell clone is continuously under the influence of the mutator. In such case the production of monoclonal protein may be related to tuberculous infection.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Retrospective
    Study Start Date :
    Jun 1, 2005
    Study Completion Date :
    Jun 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      0 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Monoclonal Gammopathy with Tuberculosis
      Exclusion Criteria:
      • No

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Laboratory Medicine, National Taiwan Univeristy Hospital Taipei Taiwan 100

      Sponsors and Collaborators

      • National Taiwan University Hospital

      Investigators

      • Principal Investigator: LINA LEE, MD,PhD, Department of labrotoary medicine,National Taiwan University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00173264
      Other Study ID Numbers:
      • 9461700601
      First Posted:
      Sep 15, 2005
      Last Update Posted:
      Sep 15, 2005
      Last Verified:
      May 1, 2005
      Additional relevant MeSH terms:
      Tuberculosis
      Paraproteinemias
      Monoclonal Gammopathy of Undetermined Significance

      Study Results

      No Results Posted as of Sep 15, 2005