Clinical trial NCT02871856: International Lung Screen Trial (ILST)
Official title: International Lung Screen Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: The University of Queensland
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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: \[insert site name\]

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

Primary outcomes:
measure: The number of Lung cancers
timeFrame: 5 years
measure: Number of nodules
timeFrame: 5 years
measure: Change in quality of life
timeFrame: 5 Years
Secondary outcomes:
measure: Cancer detection rate
timeFrame: 5 years
measure: Types and number of investigations
timeFrame: 5 Years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Vancouver
country: Canada
facility: BC Cancer Research Centre
state: British Columbia
Study officials:
affiliation: UQTRC at TPCH
name: Kwun M Fong
role: PRINCIPAL_INVESTIGATOR
affiliation: British Columbia Cancer Agency
name: Steven Lam
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.