Sputum Cytology in Screening Heavy Smokers For Lung Cancer
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.
Other: cytology specimen collection procedure
Other: physiologic testing
Procedure: annual screening
Procedure: study of high risk factors
|Study Design:||Primary Purpose: Screening|
|Official Title:||Lung Cancer Screening and Tissue Procurement|
- Classification of annual sputum samples cytologically [ Designated as safety issue: No ]
- Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence [ Designated as safety issue: No ]
- Correlation of changes in sputum cytology with lung cancer incidence [ Designated as safety issue: No ]
- Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk [ Designated as safety issue: No ]
|Study Start Date:||February 1993|
|Study Completion Date:||February 1994|
|Primary Completion Date:||February 1994 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103363
|United States, Colorado|
|University of Colorado Health Sciences Center - Denver|
|Denver, Colorado, United States, 80262|
|Principal Investigator:||Timothy Kennedy||University of Colorado, Denver|