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.

Study Overview

• Status: Completed
• Conditions: Silicosis; Pneumoconiosis; Silica
• Intervention / Treatment: Diagnostic test: Tuberculosis test; Diagnostic test: Chest X-ray; Diagnostic test: Pulmonary Function Test

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Jad Kebbe, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: lung; screening; occupational health; lung disease; public health; silica; early prevention; silicosis; Oklahoma; pulmonology; Pneumoconiosis; dust exposure; community health
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Lung Diseases, Interstitial; Lung Injury; Silicosis; Pneumoconiosis
• Other Study ID Numbers: 10140 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No