NCT00188890

Brief Summary

Occupational exposure to asbestos is known increase the risk of developing cancer of the lungs (bronchogenic carcinoma) or of the pleura (mesothelioma). Symptoms are subtle and non-specific, diagnosis is often late and the prognosis consequently is dismal. Currently there is no accepted non-invasive tool for the early diagnosis of mesothelioma or lung cancer in asbestos-exposed subjects. In the last decade, low-dose computed tomography (LDCT) has been successfully developed and validated for the early diagnosis of lung cancer in high-risk smokers. Malignant mesothelioma might, in an early stage, resemble a benign pleural plaque, which is a common finding after asbestos exposure. We target to develop low-dose CT as a tool to serially image the pleural plaques, quantify their individual and overall volume, compute the growth rate with time, and, as such, identify the presence of mesothelioma early, before symptoms occur.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2019

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

14.3 years

First QC Date

September 12, 2005

Last Update Submit

October 3, 2019

Conditions

Keywords

Lung CancerMesotheliomaAsbestosScreeningEarly Diagnosis

Study Arms (1)

1

prior occupational exposure at least 20 years ago to ASBESTOS and / or documented pleural plaques on a chest x-ray Must be 30 years of age or older. NO prior cancers, except non-melanic skin cancers

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

prior exposure to asbestos and or documented pleural plaques

You may qualify if:

  • prior asbestos exposure at least 20 years ago and/or documented pleural plaques (chest x-ray evidence)
  • Resident of Ontario, Canada

You may not qualify if:

  • prior cancer (except non-melanotic skin cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Lung NeoplasmsMesotheliomaDisease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Demetris Patsios, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR
  • Marc de Perrot, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Primary Completion

July 3, 2019

Study Completion

July 3, 2019

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations