Screening Methods in Finding Lung Cancer Early in Current or Former Smokers (Pan Can)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by British Columbia Cancer Agency.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00751660
First received: September 11, 2008
Last updated: March 7, 2012
Last verified: March 2012

September 11, 2008
March 7, 2012
September 2008
March 2013   (final data collection date for primary outcome measure)
  • Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of interval lung cancer cases [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy [ Designated as safety issue: No ]
  • Number of interval lung cancer cases [ Designated as safety issue: No ]
  • Stage distribution of lung cancer cases [ Designated as safety issue: No ]
  • Prevalence of lung nodules and differences in geographic distribution across Canada [ Designated as safety issue: No ]
  • Rate of detection of other incidental significant treatable diseases [ Designated as safety issue: No ]
  • Type and costs of downstream investigation and treatment related to abnormalities found by the screening procedures, whether the final diagnosis is lung cancer or not [ Designated as safety issue: No ]
  • Potential physical and psychosocial impact on participants [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Logistics/barriers for an early detection program [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00751660 on ClinicalTrials.gov Archive Site
  • Stage distribution of lung cancer cases [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Prevalence of lung nodules and differences in geographic distribution across Canada [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Rate of detection of other incidental significant treatable diseases [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Type and costs of downstream investigation and treatment related to abnormalities found by the screening procedures, whether the final diagnosis is lung cancer or not [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Potential physical and psychosocial impact on participants [ Time Frame: 60 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Screening Methods in Finding Lung Cancer Early in Current or Former Smokers
Early Detection of Lung Cancer - A Pan Canadian Study

RATIONALE: Screening may help doctors find lung cancer sooner, when it may be easier to treat.

PURPOSE: This clinical trial is studying screening methods to see how well they find lung cancer early in current or former smokers.

OBJECTIVES:

  • To develop a new multi-modal screening strategy and integrated methods to detect lung cancer early in current and former smokers.
  • To evaluate the impact of the screening modalities on the quality of life of these participants.
  • To develop a decision analytic framework for determining the cost and effectiveness of a novel lung cancer screening strategy in Canada.

OUTLINE: This is a multicenter study.

Participants undergo spirometry at baseline. Participants also undergo spiral CT scan at baseline and then at 1 and 2 years. Participants with semi-solid or solid nodules of 5-10 mm or ground glass opacity (GGO) 8-10 mm or those with growth of an existing nodule, development of a solid component in GGO, or a new nodule undergo an additional CT scan at 3 months. Some participants also undergo autofluorescence and white light bronchoscopy and bronchial biopsies.

Blood samples are collected at baseline and then annually for 2 years for biomarker studies. Participants diagnosed with lung cancer undergo additional blood sample collection for biomarker studies.

Participants complete questionnaires on sociodemographic factors, smoking, occupational exposure, family history, medical data, quality of life, and anxiety at baseline and then every 6 months for up to 2 years.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Lung Cancer
  • Tobacco Use Disorder
  • Other: laboratory biomarker analysis
  • Other: screening questionnaire administration
  • Procedure: bronchoscopic and lung imaging studies
  • Procedure: computed tomography
  • Procedure: endoscopic biopsy
  • Procedure: quality-of-life assessment
Not Provided
McWilliams A, Tammemagi MC, Mayo JR, Roberts H, Liu G, Soghrati K, Yasufuku K, Martel S, Laberge F, Gingras M, Atkar-Khattra S, Berg CD, Evans K, Finley R, Yee J, English J, Nasute P, Goffin J, Puksa S, Stewart L, Tsai S, Johnston MR, Manos D, Nicholas G, Goss GD, Seely JM, Amjadi K, Tremblay A, Burrowes P, MacEachern P, Bhatia R, Tsao MS, Lam S. Probability of cancer in pulmonary nodules detected on first screening CT. N Engl J Med. 2013 Sep 5;369(10):910-9. doi: 10.1056/NEJMoa1214726.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2504
Not Provided
March 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Current or former smoker

    • A former smoker is defined as one who has stopped smoking ≥ 1 year but < 15 years ago
  • Estimated 1-year lung cancer risk ≥ 1%

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Not pregnant
  • Willing to undergo a spiral chest CT scan
  • No severe heart disease (e.g., unstable angina or chronic congestive heart failure)
  • No acute or chronic respiratory failure
  • No bleeding disorder
  • No other medical condition that, in the opinion of the investigator, would preclude the participant's safety during study participation or that would unlikely benefit the participant from screening due to shortened life expectancy from the co-morbidity
  • No diagnosis of cancer, except for any of the following that were previously treated ≥ 5 years ago:

    • Non-melanomatous skin cancer
    • Localized prostate cancer
    • Carcinoma in situ of the cervix
    • Superficial bladder cancer
  • No known reaction to xylocaine, salbutamol, midazolam, or alfentanil

PRIOR CONCURRENT THERAPY:

  • More than 2 years since prior chest CT scan
  • No concurrent anti-coagulant treatment (e.g., warfarin or heparin)
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00751660
CDR0000598586, BCCA-H08-01132
No
British Columbia Cancer Agency
British Columbia Cancer Agency
Not Provided
Principal Investigator: Stephen Lam, MD British Columbia Cancer Agency
British Columbia Cancer Agency
March 2012

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