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Non-small Cell Lung CancerILSTNCT02871856

International Lung Screen Trial (ILST)

A study testing Low dose CT in people with Non-small Cell Lung Cancer and Lung Neoplasms, run by The University of Queensland at 6 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 80 yearsHealthy volunteers can take part
What is being tested?
Low dose CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
6 sitesin 2 countries
Study dates
5 Apr 2017to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Australia5 sites

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

  • Fiona Stanley Hospital

    Perth, Western Australia, 6150

  • St Vincent's Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

Canada1 site

  • BC Cancer Research Centre

    Vancouver, British Columbia, V5Z1L3

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

[insert site name]

Being tested
Low dose CT
Keywords
Screening, Computed tomography, Lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose CTDiagnostic test

    low-dose screening CT of chest for lung cancer detection

Study groups in NCT02871856
Study groupRoleWhat they receive
SingleOtherSingle arm only, CT screening of lung
Receives: Diagnostic Test: Low dose CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of Lung cancers

    Measured: 5 years

  2. Number of nodules

    Measured: 5 years

  3. Change in quality of life

    Measured: 5 Years

Secondary outcomes (2)

  1. Cancer detection rate

    Measured: 5 years

  2. Types and number of investigations

    Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study start5 Apr 2017
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871856
Sponsor's protocol ID
HREC/16/QPCH/181
Acronym
ILST
Status last verified
Dec 2023
First submitted
8 Aug 2016
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40320382

  • Bonney A, Chua M, McCusker MW, Pascoe D, Joshi SB, Steinfort D, Marshall H, Silver JD, Xie C, Yang S, Watson J, Fogarty P, Stone E, Brims F, McWilliams A, Hu X, Rofe C, Milner B, Lam S, Fong KM, Manser R. Coronary artery calcification detected on low-dose computed tomography in high-risk participants of an Australian lung cancer screening program: A prospective observational study. Respirology. 2025 Jan;30(1):62-69. doi: 10.1111/resp.14832. Epub 2024 Sep 24.

    PubMed 39318183

  • 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.

    PubMed 38273370

  • 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.

    PubMed 36592498

  • 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.

    PubMed 34902336

  • 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.

    PubMed 32011914

Questions about this trial

What is this clinical trial studying?

A study testing Low dose CT in people with Non-small Cell Lung Cancer and Lung Neoplasms, run by The University of Queensland at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of Lung cancers (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871856, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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