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International Lung Screen Trial (ILST) (ILST)

Primary Purpose

Non-small Cell Lung Cancer, Lung Neoplasms, Respiratory Tract Neoplasms

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Low dose CT

About this trial

This is an interventional screening trial for Non-small Cell Lung Cancer focused on measuring Screening, Computed tomography, Lung cancer

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

St Vincent's Hospital
The Prince Charles Hospital
Royal Melbourne Hospital
Sir Charles Gairdner Hospital
Fiona Stanley Hospital
BC Cancer Research Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single

Arm Description

Single arm only, CT screening of lung

Outcomes

Primary Outcome Measures

The number of Lung cancers

Number of nodules

Change in quality of life

Secondary Outcome Measures

Cancer detection rate

Types and number of investigations

Full Information

NCT ID

NCT02871856

First Posted

August 8, 2016

Last Updated

November 23, 2022

Sponsor

The University of Queensland

1. Study Identification

Unique Protocol Identification Number

NCT02871856

Brief Title

International Lung Screen Trial (ILST)

Acronym

ILST

Official Title

International Lung Screen Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 5, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Queensland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Screening, Computed tomography, Lung cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single

Arm Type

Other

Arm Description

Single arm only, CT screening of lung

Intervention Type

Diagnostic Test

Intervention Name(s)

Low dose CT

Intervention Description

low-dose screening CT of chest for lung cancer detection

Primary Outcome Measure Information:

Title

The number of Lung cancers

Time Frame

5 years

Title

Number of nodules

Time Frame

5 years

Title

Change in quality of life

Time Frame

5 Years

Secondary Outcome Measure Information:

Title

Cancer detection rate

Time Frame

5 years

Title

Types and number of investigations

Time Frame

5 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kwun M Fong

Organizational Affiliation

UQTRC at TPCH

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steven Lam

Organizational Affiliation

British Columbia Cancer Agency

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Vincent's Hospital

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

The Prince Charles Hospital

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Sir Charles Gairdner Hospital

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Fiona Stanley Hospital

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

BC Cancer Research Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z1L3

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34902336

Citation

Tammemagi MC, Ruparel M, Tremblay A, Myers R, Mayo J, Yee J, Atkar-Khattra S, Yuan R, Cressman S, English J, Bedard E, MacEachern P, Burrowes P, Quaife SL, Marshall H, Yang I, Bowman R, Passmore L, McWilliams A, Brims F, Lim KP, Mo L, Melsom S, Saffar B, Teh M, Sheehan R, Kuok Y, Manser R, Irving L, Steinfort D, McCusker M, Pascoe D, Fogarty P, Stone E, Lam DCL, Ng MY, Vardhanabhuti V, Berg CD, Hung RJ, Janes SM, Fong K, Lam S. USPSTF2013 versus PLCOm2012 lung cancer screening eligibility criteria (International Lung Screening Trial): interim analysis of a prospective cohort study. Lancet Oncol. 2022 Jan;23(1):138-148. doi: 10.1016/S1470-2045(21)00590-8. Epub 2021 Dec 11.

Results Reference

derived

PubMed Identifier

32011914

Citation

Lim KP, Marshall H, Tammemagi M, Brims F, McWilliams A, Stone E, Manser R, Canfell K, Weber M, Connelly L, Bowman RV, Yang IA, Fogarty P, Mayo J, Yee J, Myers R, Atkar-Khattra S, Lam DCL, Rosell A, Berg CD, Fong KM, Lam S; ILST (International Lung Screening Trial) Investigator Consortium. Protocol and Rationale for the International Lung Screening Trial. Ann Am Thorac Soc. 2020 Apr;17(4):503-512. doi: 10.1513/AnnalsATS.201902-102OC.

Results Reference

derived

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International Lung Screen Trial (ILST)

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