Sputum Cytology in Screening Heavy Smokers For Lung Cancer

2014-08-27 03:53:38 | BioPortfolio


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.




- 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.

Study Design

Primary Purpose: Screening


Lung Cancer


cytology specimen collection procedure, physiologic testing, annual screening, study of high risk factors


University of Colorado Health Sciences Center - Denver
United States


Active, not recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:53:38-0400

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