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Early Lung Cancer Detection Using Computed Tomography

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: NCT00188734
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date September 12, 2005
First Posted Date September 16, 2005
Last Update Posted Date August 10, 2016
Study Start Date September 2003
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00188734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Lung Cancer Detection Using Computed Tomography
Official Title Lung Cancer Screening in High-risk Smokers Using Low-dose Computed Tomography
Brief Summary Early detection of lung cancer may improve treatment outcomes. Risk factors have been identified, suggesting a population which might benefit from regular screening. Lung cancer screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. The purpose of this study is to evaluate the utility of LCDT for the early diagnosis of lung cancer in Ontario.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population high risk current and former smokers
Condition Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April¬†18,¬†2007)
5000
Original Enrollment Not Provided
Actual Study Completion Date June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

55 years or older at least 10 pack-year history of smoking general good health

Exclusion Criteria:

any prior cancers except non-melanotic skin cancer

Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00188734
Other Study ID Numbers I-ELCAP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Heidi C Roberts, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date August 2016