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Clinical Trials/NCT00103363
NCT00103363
Completed
Phase 2

Lung Cancer Screening and Tissue Procurement

University of Colorado, Denver1 site in 1 country3,270 target enrollmentFebruary 1993
ConditionsLung Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
University of Colorado, Denver
Enrollment
3270
Locations
1
Primary Endpoint
Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1993
End Date
February 1994
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence

Correlation of changes in sputum cytology with lung cancer incidence

Classification of annual sputum samples cytologically

Secondary Outcomes

  • Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk

Study Sites (1)

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