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

NCT04205708 | Completed

• 1 other identifier: 10140
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Silicosis; Pneumoconiosis; Silica

Keywords

silica; public health; early prevention; silicosis; screening; Oklahoma; lung disease; pulmonology; Pneumoconiosis; lung; dust exposure; occupational health; community health

Outcome Measures

Primary Outcomes (3)

• 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

• Percentage of participants who report any exposure to silica

  Percentage of participants who report any exposure to silica

  Single point assessment at baseline survey

• Prevalence of silicosis among study group

  Percentage of participants with confirmed diagnosis of silicosis

  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

  Single point assessment at baseline survey

Interventions

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.

Also known as: 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.

Also known as: Spirometry, Forced Spirometry

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Men Male gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, community sample Participants will be recruited from waiting rooms or other common spaces at participating community health clinics.

You may qualify if:

• Male 30 years or older
• Past or present employment in dusty environment, exposed to dust at work
• Ability to consent and answer the questionnaire

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Silicosis; Lung Diseases; Pneumoconiosis

Interventions

Diagnostic Imaging; Respiratory Function Tests; Spirometry

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System

Study Officials

• Jad Kebbe, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 19, 2019
• Study Start: January 14, 2019
• Primary Completion: February 24, 2021
• Study Completion: June 10, 2022
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2 years after publication
• Access Criteria: Active Data Use Agreement or other similar agreement with the University of Oklahoma Health Sciences Center

Locations

US (1)