Sputum Cytology in Screening Heavy Smokers For Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early and plan better treatment for lung cancer. PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer.

Detailed Description
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OBJECTIVES: Primary Classify annual sputum samples cytologically in participants with or without airflow obstruction and a heavy smoking history. Correlate sputum cytological atypia (moderate atypia or worse) with lung cancer incidence in these participants. Correlate changes in sputum cytology (i.e., changes toward higher grades of atypia) with lung cancer incidence in these participants. Secondary Determine other risk factors for lung cancer (e.g., diet, family history, smoking history, and medications) that may either confound or modify the association between sputum cytology and lung cancer risk in these participants. OUTLINE: Two 3-day pooled sputum samples are collected for 6 consecutive days from participants by the spontaneous cough technique for cytopathological evaluation. Participants also complete a risk factor questionnaire and undergo a pulmonary function test by spirometry and a blood draw. Participants complete a questionnaire updating smoking, vital, and lung cancer status and undergo sputum sample collection annually. Participants are informed of sputum cytology results. PROJECTED ACCRUAL: A total of 3,400 participants (2,900 with airflow obstruction and 500 without airflow obstruction) will be accrued for this study.

Official Title
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Lung Cancer Screening and Tissue Procurement

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: cytology specimen collection procedure
* Other: physiologic testing
* Procedure: annual screening
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Current or ex-smoker with a lifetime history of cigarette smoking of ≥ 20 pack years, meeting 1 of the following criteria: Airflow obstruction FEV_1 < 75% predicted for age by spirometry FEV_1/FVC ≤ 75% by spirometry No airflow obstruction No history of lung cancer PATIENT CHARACTERISTICS: Age 25 and over Performance status Not specified Life expectancy More than 5 years Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No cancer within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cytology specimen collection procedure|nan|
|Other: physiologic testing|nan|
|Procedure: annual screening|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of annual sputum samples cytologically |  |  | 
| Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence |  |  | 
| Correlation of changes in sputum cytology with lung cancer incidence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, small cell lung cancer