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Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma

Primary Purpose

Lung Cancer, Mesothelioma

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Low-dose computed tomography Annual scan x3
Low-dose computed tomography Baseline scan only
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring Lung Cancer, Mesothelioma, Asbestos, Screening

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Calgary
  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High lung cancer risk

Low lung cancer risk

Arm Description

Individuals with lung cancer risk >= 1.5% over 6 years

Individuals with lung cancer risk <1.5% over 6 years

Outcomes

Primary Outcome Measures

Change in SF-12 quality of life score

Secondary Outcome Measures

Change in EQ-5D and STAI
Lung cancer detection rate
Mesothelioma detection rate

Full Information

First Posted
November 27, 2014
Last Updated
May 16, 2022
Sponsor
University of Calgary
Collaborators
Alberta Cancer Foundation, Western Canadian Mesothelioma Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02385812
Brief Title
Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma
Official Title
Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment through COVID pandemic
Study Start Date
January 1, 2015 (undefined)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Cancer Foundation, Western Canadian Mesothelioma Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Mesothelioma
Keywords
Lung Cancer, Mesothelioma, Asbestos, Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High lung cancer risk
Arm Type
Experimental
Arm Description
Individuals with lung cancer risk >= 1.5% over 6 years
Arm Title
Low lung cancer risk
Arm Type
Experimental
Arm Description
Individuals with lung cancer risk <1.5% over 6 years
Intervention Type
Procedure
Intervention Name(s)
Low-dose computed tomography Annual scan x3
Intervention Description
Annual scan x3
Intervention Type
Procedure
Intervention Name(s)
Low-dose computed tomography Baseline scan only
Intervention Description
Baseline scan only
Primary Outcome Measure Information:
Title
Change in SF-12 quality of life score
Time Frame
Baseline vs. 14 days post receipt of screen results.
Secondary Outcome Measure Information:
Title
Change in EQ-5D and STAI
Time Frame
Baseline vs. 14 days post receipt of screen results.
Title
Lung cancer detection rate
Time Frame
3 years
Title
Mesothelioma detection rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Tremblay, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

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Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma

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