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

NCT ID: NCT01719068

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mesothelioma Lung Cancer

Keywords

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Mesothelioma Lung Cancer Early Detection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Workers exposed to asbestos

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BC Cancer Foundation

OTHER

Sponsor Role collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Lam

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Locations

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British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sharon Gee

Role: CONTACT

Phone: 604-675-8089

Email: [email protected]

Facility Contacts

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Sharon Gee

Role: primary

Other Identifiers

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H12-01812

Identifier Type: -

Identifier Source: org_study_id