NCT01719068

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

2 years

First QC Date

October 30, 2012

Last Update Submit

October 30, 2012

Conditions

Keywords

MesotheliomaLung CancerEarly Detection

Outcome Measures

Primary Outcomes (1)

  • Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma

    3 years

Study Arms (1)

Workers exposed to asbestos

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Workers in British Columbia who have been exposed to asbestos.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z1L3, Canada

RECRUITING

MeSH Terms

Conditions

MesotheliomaLung Neoplasms

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stephen Lam

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 1, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations