Occupational Exposed PopulationNCT00511251
Analysis of Induced Sputum and Lung Biopsies by SEM: a Tool to Identify Source of Exposure of Workers to Hazardous Dust
An observational study of Occupational Exposed Population, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Occupational Exposed Population
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2005to Apr 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Occupational exposed workers
Who cannot join
None listed.
About this study
Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.
Read the detailed description
Abstract
Background: On the last few years there is a rise in the public awareness of the danger potential that lies in the exposure to hazardous dust in different professions. The examination of induced sputum has been used from the early eighties to research and diagnose inflammatory lung diseases. We assess here patients with lung disease and occupational history, in order to undergo work up to assess hazardous dust exposure.
Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.
Methods: 40 patients referred with occupational history were included. For 24 of them SEM analysis was done in induced sputum (IS) together with questionnaires and in 11 among them the SEM analysis was done both from lung tissue (TS) and IS. In addition 11 lung biopsies from patients with occupational history were scanned by SEM and compared to 10 biopsies from patients with no occupational history.
- Conditions
- Occupational Exposed Population
- Keywords
- IS-SEM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startJan 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational Exposed PopulationStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational model
- Defined population
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Fireman Elizabeth, PhD, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511251
- Sponsor's protocol ID
- TASMC-07-LF-07226-CTIL
- Status last verified
- Aug 2007
- First submitted
- 2 Aug 2007
- Last updated
- 3 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Induced Sputum and Lung Biopsies by SEM: a Tool to Identify Source of Exposure of Workers to Hazardous Dust
- ClinicalTrials.gov ID
- NCT00511251
- Acronym / sponsor ID
- TASMC-07-LF-07226-CTIL
- Conditions
- Occupational Exposed Population
- Keywords
- IS-SEM
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 3 Aug 2007 (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.
Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.
Detailed description
Abstract
Background: On the last few years there is a rise in the public awareness of the danger potential that lies in the exposure to hazardous dust in different professions. The examination of induced sputum has been used from the early eighties to research and diagnose inflammatory lung diseases. We assess here patients with lung disease and occupational history, in order to undergo work up to assess hazardous dust exposure.
Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.
Methods: 40 patients referred with occupational history were included. For 24 of them SEM analysis was done in induced sputum (IS) together with questionnaires and in 11 among them the SEM analysis was done both from lung tissue (TS) and IS. In addition 11 lung biopsies from patients with occupational history were scanned by SEM and compared to 10 biopsies from patients with no occupational history.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Occupational exposed workers
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.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2007.
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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.
Fireman Elizabeth, PhD principal investigator
TASMC
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposed Population, run by Tel-Aviv Sourasky Medical Center.
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: finished, as of the sponsor's last update on 3 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 3 Aug 2007.