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Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma

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ClinicalTrials.gov Identifier: NCT02385812
Recruitment Status : Recruiting
First Posted : March 11, 2015
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Alberta Cancer Foundation
Western Canadian Mesothelioma Foundation
Information provided by (Responsible Party):
Dr. Alain Tremblay, University of Calgary

Brief Summary:
Asbestos defines a group of naturally occurring mineral silicate fibers which are easily inhaled, resulting in a variety of diseases of the respiratory system including lung cancer and malignant mesothelioma. Despite some advances in treatment, there has been little impact on overall survival for both lung cancer and mesothelioma in the past 20 years in great part because patients usually present with disease at an advanced and incurable stage. This study aims to develop and implement a low-dose computed tomography (LDCT) screening approach for lung cancer and mesothelioma in asbestos-exposed workers in Alberta.

Condition or disease Intervention/treatment Phase
Lung Cancer Mesothelioma Procedure: Low-dose computed tomography Annual scan x3 Procedure: Low-dose computed tomography Baseline scan only Phase 2

Detailed Description:

In Canada, lung cancer is the primary cause of cancer mortality above the next three culprits combined (breast, colon and prostate cancer). Cigarette smoking is the most important risk factor in the development of lung cancer. Another population of particular interest in Alberta involves workers with occupational exposure to asbestos as asbestos and tobacco exposure results in a synergistic effect on lung cancer risk. Mesothelioma is a rare cancer of the lining of the lung with poor prognosis of which 80% of cases are believed to be related to asbestos exposure.

Unfortunately, despite some advances in treatment, there has been little impact on overall survival for both lung cancer and mesothelioma in the past 20 years in great part because patients usually present with disease at an advanced and incurable stage. Additional strategies are desperately needed to reduce the morbidity and mortality associated with this disease.

The objectives of this study are to develop and implement a LDCT screening approach for lung cancer and mesothelioma in asbestos-exposed workers in Alberta; to determine participants' motivation and expectations associated with a screening program, their satisfaction with the program, and the psychosocial consequences of the screening program; to determine the accuracy of a lung cancer risk prediction model modified to include asbestos exposure; and to determine the 3-year clinical incidence of lung cancer in asbestos-exposed individuals interested in lung cancer screening but who do not meet minimal risk threshold.

The investigators will offer a combined lung cancer and mesothelioma screening program for 200 Alberta asbestos-exposed workers based on low-dose CT scanning.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma
Study Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High lung cancer risk
Individuals with lung cancer risk >= 1.5% over 6 years
Procedure: Low-dose computed tomography Annual scan x3
Annual scan x3

Experimental: Low lung cancer risk
Individuals with lung cancer risk <1.5% over 6 years
Procedure: Low-dose computed tomography Baseline scan only
Baseline scan only




Primary Outcome Measures :
  1. Change in SF-12 quality of life score [ Time Frame: Baseline vs. 14 days post receipt of screen results. ]

Secondary Outcome Measures :
  1. Change in EQ-5D and STAI [ Time Frame: Baseline vs. 14 days post receipt of screen results. ]
  2. Lung cancer detection rate [ Time Frame: 3 years ]
  3. Mesothelioma detection rate [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 50 - 80 years (either gender, any ethnic group)
  • Documented exposure to asbestos for at least one year, at least 10 years prior to study entry
  • Ability to provide informed consent and participate in study procedures

Exclusion Criteria:

  • Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), severe lung disease or lung disease requiring supplemental oxygen, solid organ transplant, that in the opinion of the physician unlikely to benefit from screening due to shortened life-expectancy from the co-morbidities or inability to tolerate diagnosis and treatment of a screen detected abnormality
  • Have been previously diagnosed with lung cancer or 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
  • CT scan of the chest in the past 2 years
  • Unwilling to have a LDCT of chest
  • Unwilling to sign a consent

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): NCT02385812


Contacts
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Contact: Alain Tremblay, MD 403-210-3866 atrembla@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Rommy Koetzler    403-210-6862    lung.screening@ucalgary.ca   
Principal Investigator: Alain Tremblay         
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Eric Bedard         
Sponsors and Collaborators
University of Calgary
Alberta Cancer Foundation
Western Canadian Mesothelioma Foundation
Investigators
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Principal Investigator: Alain Tremblay, MD University of Calgary

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Responsible Party: Dr. Alain Tremblay, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02385812     History of Changes
Other Study ID Numbers: 10007822
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Keywords provided by Dr. Alain Tremblay, University of Calgary:
Lung Cancer
Mesothelioma
Asbestos
Screening
Additional relevant MeSH terms:
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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