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

Lung Cancer Clinical Trial

— Pan Can  

Official title:

Early Detection of Lung Cancer - A Pan Canadian Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00751660
• Other study ID #: CDR0000598586
• Secondary ID: BCCA-H08-01132
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2008
• Last updated: March 7, 2012
• Start date: September 2008

Study information

• Verified date: March 2012
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2504
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Tobacco Use Disorder

Intervention

Other:
• laboratory biomarker analysis

• screening questionnaire administration

Procedure:
• bronchoscopic and lung imaging studies

• computed tomography

• endoscopic biopsy

• quality-of-life assessment

Locations

Country	Name	City	State
Canada	University of Calgary Health Sciences Centre	Calgary	Alberta
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	L'Hopital Laval	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy		24 months	No
Primary	Number of interval lung cancer cases		60 months	No
Secondary	Stage distribution of lung cancer cases		60 months	No
Secondary	Prevalence of lung nodules and differences in geographic distribution across Canada		60 months	No
Secondary	Rate of detection of other incidental significant treatable diseases		60 months	No
Secondary	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		60 months	No
Secondary	Potential physical and psychosocial impact on participants		60 months	No