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OpenTrials
Completed

NCT Number: NCT04205708

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

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.

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Key information

Conditions

Silicosis Lung Diseases Lung Diseases, Interstitial Lung Injury Occupational Diseases Pneumoconiosis Pneumoconiosis; Silica Respiratory Tract Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tuberculosis test

Diagnostic 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.

Other names: Mantoux skin test, QuantiFeron test

Chest X-Ray

Diagnostic 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 Test

Diagnostic 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.

Other names: Spirometry, Forced Spirometry

Primary outcomes

  1. 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)

  2. 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

  3. Prevalence of silicosis among study group

    Time frame: Single point assessment at clinic visit

    Percentage of participants with confirmed diagnosis of silicosis

Secondary outcomes

  1. Analysis to determine if any demographic, work history, or other trait correlates with increased silica exposure

    Time frame: Single point assessment at baseline survey

    Analysis to determine if any demographic, work history, or other trait correlates with increased silica exposure

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 19, 2019
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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