NCT00311207

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 5, 2006

Status Verified

April 1, 2006

First QC Date

March 24, 2006

Last Update Submit

April 3, 2006

Conditions

TuberculosisLung CancerPneumonia

Keywords

diagnostic kitimmunochromatography testPCR detection kitluminex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

MeSH Terms

Conditions

TuberculosisLung NeoplasmsPneumonia

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesRespiratory Tract Infections

Study Officials

  • Shen Gwan Han, MD

    Respiratory and Critical care medicine department of Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen Gwan Han, MD

CONTACT

886-4-23592525911B@vghtc.gov.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2006

First Posted

April 5, 2006

Study Start

December 1, 2005

Study Completion

November 1, 2006

Last Updated

April 5, 2006

Record last verified: 2006-04

Locations

TW(1)