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Trial record 1 of 1 for:    NCT02871856
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International Lung Screen Trial (ILST) (ILST)

This study is not yet open for participant recruitment.
Verified November 2016 by Kwun Fong, The University of Queensland
Sponsor:
ClinicalTrials.gov Identifier:
NCT02871856
First Posted: August 18, 2016
Last Update Posted: November 9, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kwun Fong, The University of Queensland
August 8, 2016
August 18, 2016
November 9, 2016
January 2017
December 2023   (Final data collection date for primary outcome measure)
  • The number of Lung cancers [ Time Frame: 5 years ]
  • Number of nodules [ Time Frame: 5 years ]
  • Change in quality of life [ Time Frame: 5 Years ]
Same as current
Complete list of historical versions of study NCT02871856 on ClinicalTrials.gov Archive Site
  • Cancer detection rate [ Time Frame: 5 years ]
  • Types and number of investigations [ Time Frame: 5 Years ]
Same as current
Not Provided
Not Provided
 
International Lung Screen Trial (ILST)
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.
[insert site name]
Interventional
Phase 2
Primary Purpose: Screening
  • 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
Radiation: Low dose CT
Single
Single arm only, CT screening of lung
Intervention: Radiation: Low dose CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
Not Provided
December 2023
December 2023   (Final data collection date for primary outcome measure)
  • 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 predictionmodel 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
Sexes Eligible for Study: All
55 Years to 80 Years   (Adult, Senior)
Yes
Contact: Kwun M Fong + 61 7 31394111 lungscreen@health.qld.gov.au
Contact: Henry M Marshall + 61 7 31394111 lungscreen@health.qld.gov.au
Not Provided
 
 
NCT02871856
HREC/16/QPCH/181
Yes
Not Provided
Plan to Share IPD: No
Kwun Fong, The University of Queensland
The University of Queensland
Not Provided
Principal Investigator: Kwun M Fong UQTRC at TPCH
The University of Queensland
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP