Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma

May 16, 2022 updated by: Dr. Alain Tremblay, University of Calgary
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada
        • University of Alberta

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in SF-12 quality of life score
Time Frame: Baseline vs. 14 days post receipt of screen results.
Baseline vs. 14 days post receipt of screen results.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Alberta Cancer Foundation
Western Canadian Mesothelioma Foundation

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

January 1, 2015

Primary Completion (ACTUAL)

April 1, 2022

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

March 10, 2015

First Posted (ESTIMATE)

March 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10007822

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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