NCT02385812

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

November 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

7.3 years

First QC Date

November 27, 2014

Last Update Submit

May 16, 2022

Conditions

Lung CancerMesothelioma

Keywords

Lung CancerMesotheliomaAsbestosScreening

Outcome Measures

Primary Outcomes (1)

  • Change in SF-12 quality of life score

    Baseline vs. 14 days post receipt of screen results.

Secondary Outcomes (3)

  • Change in EQ-5D and STAI

    Baseline vs. 14 days post receipt of screen results.

  • Lung cancer detection rate

    3 years

  • Mesothelioma detection rate

    3 years

Study Arms (2)

High lung cancer risk

EXPERIMENTAL

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

Procedure: Low-dose computed tomography Annual scan x3

Low lung cancer risk

EXPERIMENTAL

Individuals with lung cancer risk \<1.5% over 6 years

Procedure: Low-dose computed tomography Baseline scan only

Interventions

Low-dose computed tomography Annual scan x3PROCEDURE

Annual scan x3

High lung cancer risk
Low-dose computed tomography Baseline scan onlyPROCEDURE

Baseline scan only

Low lung cancer risk

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Lung NeoplasmsMesothelioma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Mesothelial

Study Officials

  • Alain Tremblay, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2014

First Posted

March 11, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

CA(2)