Added: April 29th, 2014. Last updated: April 29th, 2014.
Please note: the estimated primary completion date for this study of October, 2014 has passed. However, it is not listed as closed by ClinicalTrials.gov. Inquire with the study contacts (listed below) to determine if they are still accepting participants or for more information about the treatment protocol.
Purpose: This is a pilot study that aims to develop a lung cancer screening program for workers in British Columbia, Canada exposed to asbestos who are at risk of developing lung cancer/pleural mesothelioma. This is high risk population is at of respiratory system diseases as a result of their occupational exposures. Additionally, knowledge garnered from this study will allow us to develop other studies that will further our understanding of asbestos related lung cancer and mesothelioma.
Primary Outcome Measures:
- Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Study Population
- Workers in British Columbia who have been exposed to asbestos.
- Inclusion Criteria:
- Women or men age 50 to 79 years
- history of exposure to asbestos at work and one or more of the following:
- lung cancer risk ≥2% over 3 years or
- asbestosis or pleural plaques on a chest x-ray or
- abnormal auto-antibodies level using the EarlyCDT test
- Capable of providing informed consent for screening procedures (low dose spiral CT, lung function, blood biomarkers).
- Exclusion Criteria:
- Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, or any disorder, that in the opinion of the physician unlikely to benefit from screening due to shortened life-expectancy from co-existing illnesses
- Have been previously diagnosed with mesothelioma
- Have had other cancer within the past 5 years with the exception of the following cancers: non-melanomatous skin cancer,localized prostate cancer, carcinoma in situ (CIS) of the cervix, or superficial bladder cancer. Treatment of the exceptions must have ended >6 months before registration into this study
- Unwilling to have a low dose CT scan of chest
- Unwilling to sign a consent
Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: Tuesday, April 29th, 2014.
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