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
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Early Detection of Lung Cancer - A Pan Canadian Study

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2504
Study Start Date: September 2008
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751660

Locations
Canada, Alberta
University of Calgary Health Sciences Centre
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada
L'Hopital Laval
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Stephen Lam, MD British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided by British Columbia Cancer Agency

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00751660     History of Changes
Other Study ID Numbers: CDR0000598586, BCCA-H08-01132
Study First Received: September 11, 2008
Last Updated: March 7, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by British Columbia Cancer Agency:
small cell lung cancer
non-small cell lung cancer
tobacco use disorder

Additional relevant MeSH terms:
Lung Neoplasms
Tobacco Use Disorder
Chemically-Induced Disorders
Lung Diseases
Mental Disorders
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Substance-Related Disorders
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014