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

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ClinicalTrials.gov Identifier: NCT01719068
Recruitment Status : Unknown
Verified October 2012 by British Columbia Cancer Agency.
Recruitment status was:  Recruiting
First Posted : November 1, 2012
Last Update Posted : November 1, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Mesothelioma Lung Cancer

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos
Study Start Date : October 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Workers exposed to asbestos


Outcome Measures

Primary Outcome Measures :
  1. Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Workers in British Columbia who have been exposed to asbestos.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719068


Contacts
Contact: Sharon Gee 604-675-8089 sgee@bccancer.bc.ca

Locations
Canada, British Columbia
British Columbia Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z1L3
Contact: Sharon Gee    604-675-8089    sgee@bccancer.bc.ca   
Principal Investigator: Stephen Lam, MD         
Sub-Investigator: Annette McWilliams, MD         
Sub-Investigator: Tawimas Shaipanich, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
BC Cancer Foundation
Investigators
Principal Investigator: Stephen Lam British Columbia Cancer Agency
More Information

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01719068     History of Changes
Other Study ID Numbers: H12-01812
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by British Columbia Cancer Agency:
Mesothelioma
Lung Cancer
Early Detection

Additional relevant MeSH terms:
Lung Neoplasms
Mesothelioma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial