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NCT00173264 Clinical Trial

Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis

Tuberculosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00173264
Other study ID # 9461700601
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2005
Last updated September 12, 2005
Start date June 2005
Est. completion date June 2005

Study information
Verified date May 2005
Source National Taiwan University Hospital
Contact Lina Lee, MD,PhD
Phone 886-2-23123456
Email linalee@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Monoclonal Gammopathy with Tuberculosis

Exclusion Criteria:

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Department of Laboratory Medicine, National Taiwan Univeristy Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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