Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos

Lung Cancer Clinical Trial

Official title:

Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01719068
• Other study ID #: H12-01812
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2012
• Last updated: October 30, 2012
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2012
• Source: British Columbia Cancer Agency
• Contact: Sharon Gee
• Phone: 604-675-8089
• Email: sgee[@]bccancer.bc.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

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

• Pregnancy

• Unwilling to have a low dose CT scan of chest

• Unwilling to sign a consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Mesothelioma

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	BC Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma		3 years	No