NCT01676142

Unknown

Establishing a Diagnostic Test for Non-tuberculous Mycobacte...

National Taiwan University Hospital Source

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Other study identifiers

Sponsor study identifier

201012082RC

Study Type

observational

Estimated enrollment

200

Locations

1 country

Sites

1

Timeline

Study Start

January 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

January 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

1.To compare TLR-2 expression of peripheral blood mononuclear cells and serum downstream cytokines in those with MAC or MAB pulmonary infection and those with MAC or MAB pulmonary colonization and controls.
2.To investigate the response of TLR-2 expression and cytokines activation to NTM stimulation test in patients with MAC or MAB pulmonary infection and colonization and controls.
3.To validate the NTM stimulation test for NTM pulmonary infection.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 200 participants
Study completion date: January 2014
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 28, 2012
Actual (reported)
First Posted
August 30, 2012
Actual (reported)
Primary Completion
January 2014
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2014
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: August 30, 2012
Status Verified: June 2011
Last Update Submitted: August 28, 2012

Conditions

To Set up NTM Stimulation Test Foar Diagnosing NTM Pulmonary Infectionon.

Outcome Measures

Primary Outcomes (1)

Patients with non-tuberculous pulmonary infection
3 year

Secondary Outcomes (1)

mortality
3 years

Study Arms (3)

Patients with NTM pulmonary infection

Patients with other pathogen related lung infection

Patient with NTM pulmonary colonization

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

1. Patients with NTM pulmonary infection: diagnosed by NTM guidelines by American Thoracic Society(ATS) 2. Patients with NTM pulmonary colonization: Patients are not fulfilling the ATS diagnostic criteria but having at least one set of positive sputum for NTM (colonization). 3. Patients have pulmonary infiltrates, not related by NTM: three sets of respiratory specimens that are negative for NTM.

You may qualify if:

Sponsors & Collaborators

National Taiwan University Hospital
Otherlead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Chin-Chung Shu, MDCONTACT886972653087

Chin-Chung Shu, MDPRINCIPAL INVESTIGATOR

Study Officials

Chin-Chung Shu, MD
National Taiwan University Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Chung Shu, MD

CONTACT

886972653087 chinchungshu@ntu.edu.tw

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

January 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2014

Estimated (date passed)

Age ≥ 18 years

A patient has at least 3 sets of respiratory specimen for mycobacterial culture.

You may not qualify if:

Age younger than 18 years.
Patients who have pregnancy.
Patients who have acquired immunodeficiency syndrome
Patients who have bleeding tendency which can not tolerate venous puncture such as hemophilia, thrombocytopenia.
In NTM infection group, patients having received anti-NTM treatment for one week will be excluded.

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

January 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

August 30, 2012

Record last verified: 2011-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01676142
Data provider: ClinicalTrials.gov
Source updated: 2012-08-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:52 UTC

Locations

TW(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Patients with NTM pulmonary infection

Patients with other pathogen related lung infection

Patient with NTM pulmonary colonization

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations