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International Lung Screen Trial (ILST) (ILST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02871856
Recruitment Status : Active, not recruiting
First Posted : August 18, 2016
Last Update Posted : January 27, 2020
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]

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
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Australia, New South Wales
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Australia, Queensland
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
Fiona Stanley Hospital
Perth, Western Australia, Australia, 6150
Canada, British Columbia
BC Cancer Research Centre
Vancouver, British Columbia, Canada, V5Z1L3
Sponsors and Collaborators
The University of Queensland
Investigators
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Principal Investigator: Kwun M Fong UQTRC at TPCH
Principal Investigator: Steven Lam British Columbia Cancer Agency
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kwun Fong, Professor, The University of Queensland
ClinicalTrials.gov Identifier: NCT02871856    
Other Study ID Numbers: HREC/16/QPCH/181
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Lung Neoplasms
Neoplasms by Site
Thoracic Neoplasms
Respiratory Tract Neoplasms
Lung Diseases
Neoplasms
Respiratory Tract Diseases