NCT00212498

Brief Summary

To create a Tuberculosis Research Blood Bank for future molecular genetics and serological studies

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

5.2 years

First QC Date

September 13, 2005

Last Update Submit

December 7, 2015

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Develop TB Blood Bank

    To develop a bank of blood samples (serum, plasma, buffy coat DNA) and urine from patients infected with TB. This blood and urine will be used for future molecular genetics studies. Demographic data will be collected and samples will be stored by number. The banked specimens will be evaluated in an attempt to identify susceptibility genes in TB disease. Specifically, expression of the human Bcg gene that codes for resistance to M. tuberculosis will be evaluated and its expression correlated expression with gender, race, clinical TB characteristics. Each patient will have a unique identifier and therefore data generated from this analysis will not be linkable to the patient.

    Long-Term

Study Arms (1)

TB diagnosis

Procedure: Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies

Interventions

Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studiesPROCEDURE

Blood sample

TB diagnosis

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

TB patients

You may qualify if:

  • TB suspect with positive sputum smear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine Division of Pulmonary and Critical Care Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Rany Condos, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2006

Primary Completion

January 1, 2012

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

US(1)