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International Lung Screen Trial (ILST) (ILST)

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ClinicalTrials.gov Identifier: NCT02871856
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Kwun Fong, The University of Queensland

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.

Condition or disease Intervention/treatment Phase
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 Diagnostic Test: Low dose CT Not Applicable

Detailed Description:
[insert site name]

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: International Lung Screen Trial
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single
Single arm only, CT screening of lung
Diagnostic Test: Low dose CT
low-dose screening CT of chest for lung cancer detection




Primary Outcome Measures :
  1. The number of Lung cancers [ Time Frame: 5 years ]
  2. Number of nodules [ Time Frame: 5 years ]
  3. Change in quality of life [ Time Frame: 5 Years ]

Secondary Outcome Measures :
  1. Cancer detection rate [ Time Frame: 5 years ]
  2. Types and number of investigations [ Time Frame: 5 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871856


Contacts
Contact: Kwun M Fong + 61 7 31394111 lungscreen@health.qld.gov.au
Contact: Henry M Marshall + 61 7 31394111 lungscreen@health.qld.gov.au

Locations
Australia, New South Wales
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Robert Kent    0293555611    SVHS.CancerResearch@svha.org.au   
Principal Investigator: Emily Stone         
Australia, Queensland
The Prince Charles Hospital Recruiting
Brisbane, Queensland, Australia, 4032
Contact: Linda Passmore    0731396632    Lungscreen@health.qld.gov.au   
Contact: Liz McCaul    0731396632    Lungscreen@health.qld.gov.au   
Principal Investigator: Kwun Fong         
Australia, Victoria
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Shelley Mesfin    03 93424707    RMH-Lungscreening@mh.org.au   
Contact: Stewart Duncum    03 93424707    RMH-Lungscreening@mh.org.au   
Principal Investigator: Renee Manser         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Perth, Western Australia, Australia, 6009
Contact: Jacqueline Logan    0861511238    FSH.InternationalLungScreenTrial@health.wa.gov.au   
Principal Investigator: Fraser Brims         
Fiona Stanley Hospital Recruiting
Perth, Western Australia, Australia, 6150
Contact: Jacqueline Logan    0861511238    FSH.InternationalLungScreenTrial@health.wa.gov.au   
Principal Investigator: Annette McWilliams         
Canada, British Columbia
BC Cancer Research Centre Recruiting
Vancouver, British Columbia, Canada, V5Z1L3
Contact: Sukhinder Atkar-Khattra    1-604-675-8000 ext 7095    Bclungscreening2015@gmail.com   
Contact    1-604-675-8094      
Principal Investigator: Stephen Lam         
Sponsors and Collaborators
The University of Queensland
Investigators
Principal Investigator: Kwun M Fong UQTRC at TPCH
Principal Investigator: Steven Lam British Columbia Cancer Agency

Responsible Party: Kwun Fong, Professor, The University of Queensland
ClinicalTrials.gov Identifier: NCT02871856     History of Changes
Other Study ID Numbers: HREC/16/QPCH/181
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kwun Fong, The University of Queensland:
Screening
Computed tomography
Lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Site
Thoracic Neoplasms
Respiratory Tract Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms