SilicosisNCT04205708
Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
An observational study of Silicosis and Pneumoconiosis; Silica, run by University of Oklahoma at 1 site in United States.
Trial summary
Silicosis, a preventable yet irreversible occupational lung disease, has an insidious onset with a latency period for diagnosis extending beyond 10 years from the initial exposure. The central hypothesis of this study is that silicosis cases may currently be going undetected. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Silicosis, Pneumoconiosis; Silica
- What is being tested?
- Tuberculosis test, Chest X-ray and Pulmonary Function Test
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 10 Jun 2022
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic, community sample Participants will be recruited from waiting rooms or other common spaces at participating community health clinics.
Who may be able to join
- Male 30 years or older
- Past or present employment in dusty environment, exposed to dust at work
- Ability to consent and answer the questionnaire
Who cannot join
- Female
- Never exposed to dusty environment or never exposed to dust at work
- Inability to consent and answer the questionnaire
- Age 29 years or younger
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Silicosis, a preventable yet irreversible occupational lung disease, has an insidious onset with a latency period for diagnosis extending beyond 10 years from the initial exposure. The central hypothesis of this study is that silicosis cases may currently be going undetected. The long-term goal of this research is to determine the current prevalence and forecast the future prevalence of silicosis and other pneumoconiosis among working populations in Oklahoma and to assist the public health and the healthcare system in planning for a potential resurgence of silicosis.
- Conditions
- Silicosis, Pneumoconiosis; Silica
- Being tested
- Tuberculosis test, Chest X-ray, Pulmonary Function Test
- Keywords
- silica, public health, early prevention, silicosis, screening, Oklahoma, lung disease, pulmonology, Pneumoconiosis, lung, dust exposure, occupational health, community health
- Medical subject headings
- Silicosis, Lung Diseases, Pneumoconiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculosis testDiagnostic test
Also called Mantoux skin test, QuantiFeron test
Tuberculosis (TB) test: A blood sample is collected for lab testing to determine if you have tuberculosis (QuantiFeron test). Alternatively, the test is done by injecting a small amount of fluid (called tuberculin) into the skin on the lower part of the arm. A person given the tuberculin skin test must return within 48 to 72 hours to have a trained health care worker look for a reaction on the arm.
Chest X-rayDiagnostic test
Chest X ray: non-invasive medical test that helps physicians diagnose and treat medical conditions of the lungs and chest. The Chest X-ray will be done to check for abnormalities on the lungs. The test is non-invasive.
Pulmonary Function TestDiagnostic test
Also called Spirometry, Forced Spirometry
A pulmonary function test (PFT, spirometry) is a breathing test that measures how much air your lungs can hold as well as how hard and fast you can blow air out of your lungs. The test is not invasive and involves blowing into a machine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative)
Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative)
Measured: Single point assessment at baseline survey
Percentage of participants who report any exposure to silica
Percentage of participants who report any exposure to silica
Measured: Single point assessment at baseline survey
Prevalence of silicosis among study group
Percentage of participants with confirmed diagnosis of silicosis
Measured: Single point assessment at clinic visit
Secondary outcomes (1)
Analysis to determine if any demographic, work history, or other trait correlates with increased silica exposure
Analysis to determine if any demographic, work history, or other trait correlates with increased silica exposure
Measured: Single point assessment at baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start14 Jan 2019
- Primary completion24 Feb 2021
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SilicosisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jad Kebbe, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205708
- Sponsor's protocol ID
- 10140
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2019
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers may request a deidentified dataset. The de-identified dataset may be shared between other investigators of the same institution as the PI, in accordance with University and Institutional Review Board policies. Any investigator not affiliated with the University of Oklahoma Health Sciences Center who desires access to a de-identified dataset may do so by coordinating a Data Use Agreement between the investigator's institution and the PI's institution. Datasets will only be released with an active Data Use Agreement or other similar agreement with the University of Oklahoma Health Sciences Center.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
- ClinicalTrials.gov ID
- NCT04205708
- Acronym / sponsor ID
- 10140
- Conditions
- Silicosis, Pneumoconiosis; Silica
- Keywords
- silica, public health, early prevention, silicosis, screening, Oklahoma, lung disease, pulmonology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 19 Dec 2019 (actual)
- 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.
Silicosis, a preventable yet irreversible occupational lung disease, has an insidious onset with a latency period for diagnosis extending beyond 10 years from the initial exposure. The central hypothesis of this study is that silicosis cases may currently be going undetected. The long-term goal of this research is to determine the current prevalence and forecast the future prevalence of silicosis and other pneumoconiosis among working populations in Oklahoma and to assist the public health and the healthcare system in planning for a potential resurgence of silicosis.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, community sample Participants will be recruited from waiting rooms or other common spaces at participating community health clinics.
Key inclusion criteria (3 listed)
- Male 30 years or older
- Past or present employment in dusty environment, exposed to dust at work
- Ability to consent and answer the questionnaire
Key exclusion criteria (4 listed)
- Female
- Never exposed to dusty environment or never exposed to dust at work
- Inability to consent and answer the questionnaire
- Age 29 years or younger
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 |
|---|---|---|
| Tuberculosis testAlso: Mantoux skin test, QuantiFeron testTuberculosis (TB) test: A blood sample is collected for lab testing to determine if you have tuberculosis (QuantiFeron test). Alternatively, the test is done by injecting a small amount of fluid (called tuberculin) into the skin on the lower part of the arm. A person given the tuberculin skin test must return within 48 to 72 hours to have a trained health care worker look for a reaction on the arm. | Diagnostic test | – |
| Chest X-rayChest X ray: non-invasive medical test that helps physicians diagnose and treat medical conditions of the lungs and chest. The Chest X-ray will be done to check for abnormalities on the lungs. The test is non-invasive. | Diagnostic test | – |
| Pulmonary Function TestAlso: Spirometry, Forced SpirometryA pulmonary function test (PFT, spirometry) is a breathing test that measures how much air your lungs can hold as well as how hard and fast you can blow air out of your lungs. The test is not invasive and involves blowing into a machine. | Diagnostic test | – |
Primary outcome
Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative)
Time frame: Single point assessment at baseline survey
Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative)
Percentage of participants who report any exposure to silica
Time frame: Single point assessment at baseline survey
Percentage of participants who report any exposure to silica
Prevalence of silicosis among study group
Time frame: Single point assessment at clinic visit
Percentage of participants with confirmed diagnosis of silicosis
1 secondary outcome
Analysis to determine if any demographic, work history, or other trait correlates with increased silica exposure
Time frame: Single point assessment at baseline survey
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 6 Dec 2023.
- Individual participant dataSharing planned: Yes. Researchers may request a deidentified dataset. The de-identified dataset may be shared between other investigators of the same institution as the PI, in accordance with University and Institutional Review Board policies. Any investigator not affiliated with the University of Oklahoma Health Sciences Center who desires access to a de-identified dataset may do so by coordinating a Data Use Agreement between the investigator's institution and the PI's institution. Datasets will only be released with an active Data Use Agreement or other similar agreement with the University of Oklahoma Health Sciences Center.
Related trials for Silicosis
Not yet recruitingObservational study
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COPD, Interstitial Pneumonia
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.
Jad Kebbe, MD principal investigator
University of Oklahoma
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 Silicosis and Pneumoconiosis; Silica, run by University of Oklahoma 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 3 inclusion and 4 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 6 Dec 2023. 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 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.
What does the primary outcome measure?
Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative) (time frame: Single point assessment at baseline survey). The study lists 3 primary outcomes in all. 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 6 Dec 2023.