Sputum Cytology in Screening Heavy Smokers For Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00103363
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study Start: 1993-02
• Primary Completion: 1994-02
• Study Completion: 1994-02
• Study First Submitted: 2005-02-07
• Study First Submitted QC: 2005-02-07
• Study First Posted: 2005-02-08
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3270

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of changes in sputum cytology with lung cancer incidence
Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
Classification of annual sputum samples cytologically

Secondary Outcome Measures

Name	Time	Method
Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk

Trial Locations

Locations (1)

University of Colorado Health Sciences Center - Denver; 🇺🇸 Denver, Colorado, United States