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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Tobacco Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

screening questionnaire administration

Intervention Type OTHER

bronchoscopic and lung imaging studies

Intervention Type PROCEDURE

computed tomography

Intervention Type PROCEDURE

endoscopic biopsy

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No