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International Lung Screen Trial (ILST)

NCT ID: NCT02871856

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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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

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Screening Computed tomography Lung cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Single

Single arm only, CT screening of lung

Group Type OTHER

Low dose CT

Intervention Type DIAGNOSTIC_TEST

low-dose screening CT of chest for lung cancer detection

Interventions

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Low dose CT

low-dose screening CT of chest for lung cancer detection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Queensland

OTHER

Sponsor Role lead

Responsible Party

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Kwun Fong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kwun M Fong

Role: PRINCIPAL_INVESTIGATOR

UQTRC at TPCH

Steven Lam

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Locations

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St Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

The Prince Charles Hospital

Brisbane, Queensland, Australia

Site Status

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Site Status

Fiona Stanley Hospital

Perth, Western Australia, Australia

Site Status

BC Cancer Research Centre

Vancouver, British Columbia, Canada

Site Status

Countries

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Australia Canada

References

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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.

Reference Type DERIVED
PMID: 40320382 (View on PubMed)

Bonney A, Brodersen J, Siersma V, See K, Marshall HM, Steinfort D, Irving L, Lin L, Li J, Pang S, Fogarty P, Brims F, McWilliams A, Stone E, Lam S, Fong KM, Manser R. Validation of the psychosocial consequences of screening in lung cancer questionnaire in the international lung screen trial Australian cohort. Health Qual Life Outcomes. 2024 Jan 25;22(1):10. doi: 10.1186/s12955-023-02225-8.

Reference Type DERIVED
PMID: 38273370 (View on PubMed)

Cressman S, Weber MF, Ngo PJ, Wade S, Behar Harpaz S, Caruana M, Tremblay A, Manser R, Stone E, Atkar-Khattra S, Karikios D, Ho C, Fernandes A, Yi Weng J, McWilliams A, Myers R, Mayo J, Yee J, Yuan R, Marshall HM, Fong KM, Lam S, Canfell K, Tammemagi MC. Economic impact of using risk models for eligibility selection to the International lung screening Trial. Lung Cancer. 2023 Feb;176:38-45. doi: 10.1016/j.lungcan.2022.12.011. Epub 2022 Dec 22.

Reference Type DERIVED
PMID: 36592498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34902336 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32011914 (View on PubMed)

Other Identifiers

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HREC/16/QPCH/181

Identifier Type: -

Identifier Source: org_study_id