Trial record 2 of 3 for:    mesothelioma screening

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

This study is currently recruiting participants.
Verified October 2012 by British Columbia Cancer Agency
Sponsor:
Collaborator:
BC Cancer Foundation
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01719068
First received: October 30, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  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.


Condition
Mesothelioma
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

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 ]

Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Workers exposed to asbestos

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01719068     History of Changes
Other Study ID Numbers: H12-01812
Study First Received: October 30, 2012
Last Updated: October 30, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
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

ClinicalTrials.gov processed this record on April 16, 2014