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

British Columbia Cancer Agency

Status: Unknown

Conditions: Tobacco Use Disorder; Lung Cancer

Treatments: Procedure: quality-of-life assessment; Procedure: computed tomography; Other: laboratory biomarker analysis; Procedure: bronchoscopic and lung imaging studies; Other: screening questionnaire administration; Procedure: endoscopic biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT00751660

CDR0000598586

BCCA-H08-01132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,504 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)