Expired Study
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Denver, Colorado 80262


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.

Study summary:

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.


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



Primary Contact:

Principal Investigator
Timothy Kennedy
University of Colorado, Denver

Backup Contact:


Location Contact:

Denver, Colorado 80262
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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