Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis

NCT ID: NCT00173264

Last Updated: 2005-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Monoclonal Gammopathy Tuberculosis

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Monoclonal Gammopathy with Tuberculosis

Exclusion Criteria

* No
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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LINA LEE, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of labrotoary medicine,National Taiwan University Hospital

Locations

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Department of Laboratory Medicine, National Taiwan Univeristy Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Lina Lee, MD,PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Lina Lee, MD, PhD

Role: primary

Other Identifiers

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9461700601

Identifier Type: -

Identifier Source: org_study_id