- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00173264
Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis
September 12, 2005 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- Department of Laboratory Medicine, National Taiwan Univeristy Hospital
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Contact:
- Lina Lee, MD, PhD
- Phone Number: 5359 886-2-23123456
- Email: linalee@ntu.edu.tw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Monoclonal Gammopathy with Tuberculosis
Exclusion Criteria:
- No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: LINA LEE, MD,PhD, Department of labrotoary medicine,National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 15, 2005
Last Update Submitted That Met QC Criteria
September 12, 2005
Last Verified
May 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Blood Protein Disorders
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Hypergammaglobulinemia
- Tuberculosis
- Paraproteinemias
- Monoclonal Gammopathy of Undetermined Significance
Other Study ID Numbers
- 9461700601
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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