- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01719068
Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos
October 30, 2012 updated by: British Columbia Cancer Agency
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sharon Gee
- Phone Number: 604-675-8089
- Email: sgee@bccancer.bc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z1L3
- Recruiting
- British Columbia Cancer Agency
-
Sub-Investigator:
- Tawimas Shaipanich, MD
-
Principal Investigator:
- Stephen Lam, MD
-
Contact:
- Sharon Gee
- Phone Number: 604-675-8089
- Email: sgee@bccancer.bc.ca
-
Sub-Investigator:
- Annette McWilliams, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Workers in British Columbia who have been exposed to asbestos.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Workers exposed to asbestos
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Lam, British Columbia Cancer Agency
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
October 30, 2012
First Submitted That Met QC Criteria
October 30, 2012
First Posted (Estimate)
November 1, 2012
Study Record Updates
Last Update Posted (Estimate)
November 1, 2012
Last Update Submitted That Met QC Criteria
October 30, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H12-01812
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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