Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Screening Methods in Finding Lung Cancer Early in Current or Former Smokers

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Health services research, Screening Active 50 to 75 Other BCCA-H08-01132 H08-01132, NCT00751660

Objectives

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

Entry 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%

Prior/Concurrent Therapy:

• More than 2 years since prior chest CT scan
• No concurrent anti-coagulant treatment (e.g., warfarin or heparin)

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

Expected Enrollment

Outcomes

Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy
Number of interval lung cancer cases
Stage distribution of lung cancer cases
Prevalence of lung nodules and differences in geographic distribution across Canada
Rate of detection of other incidental significant treatable diseases
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
Potential physical and psychosocial impact on participants
Adverse events
Logistics/barriers for an early detection program

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.

Trial Contact Information

Trial Lead Organizations

British Columbia Cancer Agency - Vancouver Cancer Centre

Stephen Lam, MD, Principal investigator		Ph: 604-675-8089; 800-663-3333

Canada
Alberta
	Calgary
	University of Calgary Health Sciences Centre
		Contact Person	Ph:  403-944-1744
British Columbia
	Vancouver
	British Columbia Cancer Agency - Vancouver Cancer Centre
		Stephen Lam, MD	Ph:  604-675-8089 800-663-3333
Nova Scotia
	Halifax
	Nova Scotia Cancer Centre
		Contact Person	Ph:  902-473-1913
Ontario
	Hamilton
	Margaret and Charles Juravinski Cancer Centre
		Contact Person	Ph:  905-387-9495 1-866-966-5864
	Toronto
	Princess Margaret Hospital
		Contact Person	Ph:  416-946-4501 ext 6318
Quebec
	Quebec
	L'Hopital Laval
		Contact Person	Ph:  418-656-4810

Registry Information
Official Title		Early Detection of Lung Cancer - A Pan Canadian Study
Trial Start Date		2008-09-17
Trial Completion Date		2013-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00751660
Date Submitted to PDQ		2008-09-03
Information Last Verified		2008-12-14