International Lung Screen Trial (ILST) | NCT02871856

Studies
International Lung Screen Trial (ILST)

NCT02871856

Sponsor

The University of Queensland

Status

Unknown status

Last Update Posted

Dec 5, 2023Actual

Enrollment

2,000Estimated

Phase

Not Applicable

Conditions

Non-small Cell Lung Cancer
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Smokers at Risk of Lung Cancer

Interventions

Low dose CT

Countries

Australia
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2017Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Aug 8, 2016

First Submission Date that Met QC Criteria

Aug 15, 2016

First Posted Date

Aug 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2023

Last Update Posted Date

Dec 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

[insert site name]

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Label	Type	Description	Intervention Names
Single	Other	Single arm only, CT screening of lung	Diagnostic Test: Low dose CT

Name	Type	Description	Arm Group Labels	Other Names
Low dose CT	Diagnostic Test	low-dose screening CT of chest for lung cancer detection	Single

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

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kwun M Fong	UQTRC at TPCH	Principal Investigator
Steven Lam	British Columbia Cancer Agency	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
St Vincent's Hospital		Sydney	New South Wales	2010	Australia
The Prince Charles Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40320382	Derived	Bonney A, Pascoe DM, McCusker MW, Steinfort D, Marshall H, McWilliams A, Brims FJ, Stone E, Fogarty P, Silver JD, Milner B, Silverstone E, Hsu E, Nguyen D, Rofe C, White C, Hu X, Mayo J, Myers R, Fong KM, Manser R, Lam S. Incidental findings during lung low-dose computed tomography cancer screening in Australia and Canada, 2016-21: a prospective observational study. Med J Aust. 2025 May 5;222(8):403-411. doi: 10.5694/mja2.52649.
39318183

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms