TuberculosisNCT00212498
Tuberculosis Research Blood Bank
An observational study of Tuberculosis, run by NYU Langone Health at 1 site in United States.
Trial summary
To create a Tuberculosis Research Blood Bank for future molecular genetics and serological studies Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: TB patients
Who may be able to join
- TB suspect with positive sputum smear
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU School of Medicine Division of Pulmonary and Critical Care Medicine
New York, New York, 10016
About this study
To create a Tuberculosis Research Blood Bank for future molecular genetics and serological studies
- Conditions
- Tuberculosis
- Being tested
- Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studiesProcedure or surgery
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| TB diagnosis | Not described Receives: Procedure: Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Long-Term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2006
- Primary completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rany Condos, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212498
- Sponsor's protocol ID
- 11354 (previously 4424)
- Status last verified
- Dec 2015
- First submitted
- 13 Sep 2005
- Last updated
- 9 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberculosis Research Blood Bank
- ClinicalTrials.gov ID
- NCT00212498
- Acronym / sponsor ID
- 11354 (previously 4424)
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jan 2012 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To create a Tuberculosis Research Blood Bank for future molecular genetics and serological studies
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB diagnosis | – | Procedure: Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TB patients
Key inclusion criteria (1 listed)
- TB suspect with positive sputum smear
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studiesBlood sample | Procedure or surgery | TB diagnosis |
Primary outcome
Develop TB Blood Bank
Time frame: Long-Term
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rany Condos, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop TB Blood Bank (time frame: Long-Term). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.