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CompletedNCT04205708Updated Dec 6, 2023

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

An observational study in Silicosis and Pneumoconiosis; Silica, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by University of Oklahoma · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
183
Ages
30 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Silicosis
  • Pneumoconiosis; Silica

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Keywords

  • silica
  • public health
  • early prevention
  • silicosis
  • screening
  • Oklahoma
  • lung disease
  • pulmonology
  • Pneumoconiosis
  • lung
  • dust exposure
  • occupational health
  • community health
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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
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.

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

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
04

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
183 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testTuberculosis 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

  • Diagnostic testChest 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.

  • Diagnostic testPulmonary 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.

    Also known as: Spirometry, Forced Spirometry

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What researchers measure

Primary outcomes

  1. Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative)

    Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative)

    Time frame: Single point assessment at baseline survey

  2. Percentage of participants who report any exposure to silica

    Percentage of participants who report any exposure to silica

    Time frame: Single point assessment at baseline survey

  3. Prevalence of silicosis among study group

    Percentage of participants with confirmed diagnosis of silicosis

    Time frame: 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

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

    Time frame: Single point assessment at baseline survey

06

Study locations

1 site
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
07

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04205708
Lead sponsor
University of Oklahoma
Responsible party
Sponsor
First posted
Dec 19, 2019
Start date
Jan 14, 2019
Primary completion
Feb 24, 2021
Completion
Jun 10, 2022
Last update
Dec 6, 2023

Study contacts

Jad Kebbe, MD
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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