International Lung Screen Trial (ILST) (ILST)

December 3, 2023 updated by: Kwun Fong, The University of Queensland

International Lung Screen Trial

People who may be at increased risk of lung cancer due to age and smoking history will be invited to participate in this international study to determine the best way of using computed tomography (CT) of the chest to screen for early lung cancer. Overseas data show that CT screening (screening tests can find diseases early, when they're easier to treat) can reduce deaths from lung cancer and this study will help determine who is most likely benefit from screening.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

[insert site name]

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • The Prince Charles Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1L3
        • BC Cancer Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

  • Inclusion Criteria:
  • Women or men age from 55 to 80.
  • Current or former smokers. A former smoker is defined as one who has stopped smoking for one or more years.
  • An estimated 6-year lung cancer risk of ≥1.51% based on the PLCOm2012 risk prediction model or ≥ 30 pack-years smoking history (pack-year is defined as number of pack of cigarettes smoked per day multiply by the number of years smoked. If a participant stopped smoking for 6 months or more and then restarted smoking again, the time will be subtracted from the total duration of smoking in 0.5 year increments)
  • ECOG performance status 0 or 1.
  • Capable of providing, informed consent for screening procedures (low dose spiral CT)
  • Exclusion Criteria
  • Clinical symptoms suspicious for lung cancer e.g. hemoptysis, chest pain, weight loss
  • Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, home oxygen therapy, bleeding disorder, that in the opinion of the investigator could jeopardize the subject's safety during participation in the study or unlikely to benefit from screening due to shortened life-expectancy from the co-morbidities
  • Have been previously diagnosed with lung cancer
  • Have had other non-curatively treated cancer outside the lung.
  • Pregnancy
  • Pneumonia or bronchitis requiring antibiotic treatment within the last 12 weeks
  • Unwilling to have a spiral chest CT
  • Chest CT within 2 years
  • Does not fit into CT scanner table due to gross obesity
  • Cannot lie on CT scanning table on the back with arms over the head
  • Received chemotherapy or cytotoxic drugs within the last 6 months
  • Unwilling to sign a consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single
Single arm only, CT screening of lung
Diagnostic test: Low dose CT
low-dose screening CT of chest for lung cancer detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of Lung cancers
Time Frame: 5 years
5 years
Number of nodules
Time Frame: 5 years
5 years
Change in quality of life
Time Frame: 5 Years
5 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cancer detection rate
Time Frame: 5 years
5 years
Types and number of investigations
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Investigators

  • Principal Investigator: Kwun M Fong, UQTRC at TPCH
  • Principal Investigator: Steven Lam, British Columbia Cancer Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2017

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimated)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/16/QPCH/181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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