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Sputum Cytology in Screening Heavy Smokers For Lung Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: February 7, 2005
Last updated: May 5, 2014
Last verified: May 2014

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.

Condition Intervention Phase
Lung Cancer Other: cytology specimen collection procedure Other: physiologic testing Procedure: annual screening Procedure: study of high risk factors Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Lung Cancer Screening and Tissue Procurement

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Classification of annual sputum samples cytologically
  • Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
  • Correlation of changes in sputum cytology with lung cancer incidence

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

Enrollment: 3270
Study Start Date: February 1993
Study Completion Date: February 1994
Primary Completion Date: February 1994 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 25 and over

Performance status

  • Not specified

Life expectancy

  • More than 5 years


  • Not specified


  • Not specified


  • Not specified


  • No cancer within the past 5 years except nonmelanoma skin cancer


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00103363

United States, Colorado
University of Colorado Health Sciences Center - Denver
Denver, Colorado, United States, 80262
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Principal Investigator: Timothy Kennedy University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT00103363     History of Changes
Other Study ID Numbers: 92-0392
UCHSC-92-392 ( Other Identifier: University of Colorado Multiple Institutional Review Board )
Study First Received: February 7, 2005
Last Updated: May 5, 2014

Keywords provided by University of Colorado, Denver:
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on August 18, 2017