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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
  Purpose
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 Intervention 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 Radiation: Low dose CT Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: International Lung Screen Trial

Resource links provided by NLM:


Further study details as provided by Kwun Fong, The University of Queensland:

Primary Outcome Measures:
  • 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 ]

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

Study Start Date: January 2017
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single
Single arm only, CT screening of lung
Radiation: Low dose CT

Detailed Description:
[insert site name]
  Eligibility

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.


Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
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 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
  Contacts and Locations
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

Sponsors and Collaborators
The University of Queensland
Investigators
Principal Investigator: Kwun M Fong UQTRC at TPCH
  More Information

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 Submitted: August 8, 2016
First Posted: August 18, 2016
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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