International Lung Screen Trial (ILST)

NCT02871856 | Unknown DMC

• 1 other identifier: HREC/16/QPCH/181
• Study Type: interventional
• Target: 2,000
• Locations: 2 countries
• Sites: 6

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.

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

Keywords

Screening; Computed tomography; Lung cancer

Outcome Measures

Primary Outcomes (3)

• The number of Lung cancers

  5 years

• Number of nodules

  5 years

• Change in quality of life

  5 Years

Secondary Outcomes (2)

• Cancer detection rate

  5 years

• Types and number of investigations

  5 Years

Study Arms (1)

Single

OTHER

Single arm only, CT screening of lung

Diagnostic Test: Low dose CT

Interventions

Low dose CT DIAGNOSTIC_TEST

low-dose screening CT of chest for lung cancer detection

Single

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (6)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

Location

BC Cancer Research Centre

Vancouver, British Columbia, V5Z1L3, Canada

Location

Related Publications (5)

• 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.

  PMID: 40320382 DERIVED

• 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.

  PMID: 38273370 DERIVED

• 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.

  PMID: 36592498 DERIVED

• 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.

  PMID: 34902336 DERIVED

• 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.

  PMID: 32011914 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Kwun M Fong

  UQTRC at TPCH

  PRINCIPAL INVESTIGATOR

• Steven Lam

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 18, 2016
• Study Start: April 5, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); AU (5)