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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04205708
Other study ID # 10140
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2019
Est. completion date June 10, 2022

Study information

Verified date December 2023
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date June 10, 2022
Est. primary completion date February 24, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility Inclusion Criteria: - Male 30 years or older - Past or present employment in dusty environment, exposed to dust at work - Ability to consent and answer the questionnaire Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Tuberculosis 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-ray
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 Test
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.

Locations

Country Name City State
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative) Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative) Single point assessment at baseline survey
Primary Percentage of participants who report any exposure to silica Percentage of participants who report any exposure to silica Single point assessment at baseline survey
Primary Prevalence of silicosis among study group Percentage of participants with confirmed diagnosis of silicosis Single point assessment at clinic visit
Secondary 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 Single point assessment at baseline survey
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