Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173264
First received: September 12, 2005
Last updated: NA
Last verified: May 2005
History: No changes posted

September 12, 2005
September 12, 2005
June 2005
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No Changes Posted
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Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis
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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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Monoclonal Gammopathy
  • Tuberculosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2005
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Inclusion Criteria:

  • Monoclonal Gammopathy with Tuberculosis

Exclusion Criteria:

  • No
Both
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No
Contact: Lina Lee, MD,PhD 886-2-23123456 ext 5359 linalee@ntu.edu.tw
Taiwan
 
NCT00173264
9461700601
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National Taiwan University Hospital
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Principal Investigator: LINA LEE, MD,PhD Department of labrotoary medicine,National Taiwan University Hospital
National Taiwan University Hospital
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP