Development of Tuberculosis Diagnostic Kit

Lung Cancer Clinical Trial

Official title:

Development of Tuberculosis Diagnostic Kit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00311207
• Other study ID #: 940601/C05098
• Status: Recruiting
• Phase: Phase 3
• First received: March 24, 2006
• Last updated: April 3, 2006
• Start date: December 2005
• Est. completion date: November 2006

Study information

• Verified date: April 2006
• Source: Taichung Veterans General Hospital
• Contact: Shen Gwan Han, MD
• Phone: 886-4-23592525
• Email: 911B[@]vghtc.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Pulmonary tuberculosis is one of the most important infectious diseases in human with high mortality.

Early diagnosis followed by antibiotic treatment is the only way for control of the disease. However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity. Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine, pleura and serum samples.Capilia TB assay and another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be tried to detection tuberculous disease.

Description:

Sputum samples from 200 patients with chest or respiratory problems will be collected. Presence of M.

tuberculosis in the samples will be checked by acid-fast stain and bacterial culture and identification methods.

At the same time, saliva, urine, and serum samples from these 200 patients and 50 healthy volunteers will be collected. The tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. or capilia TB assay or another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be used to detect tuberculosis disease from these samples. By comparing the results with the stain and identification results of sputum samples from the 200 patients, the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine,pleura and serum samples, as well as from combination of these samples, will be obtained. In addition to pulmonary tuberculosis, M. tuberculosis causes pleural tuberculosis. Diagnosis of pleural tuberculosis involves determination of activities of adenosine deaminase and interferon-gamma in pleural effusion, which is tedious. We also plan to collect pleural effusion samples from 100 patients, and examined by the tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. By comparing the results with the adenosine deaminase and interferon-gamma activities of the same samples, the sensitivity and specificity of the kit in detection of pleural tuberculosis from pleural effusion samples will be obtained.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: clinical suspicious of tuberculosis

Exclusion Criteria:

• HIV

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Lung Cancer
• Pneumonia
• Tuberculosis

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan,