Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma

Silicosis Clinical Trial

Official title:

Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205708
• Other study ID #: 10140
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Pneumoconiosis
• Pneumoconiosis; Silica
• Silicosis

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