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Sputum Cytology in Screening Heavy Smokers For Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103363
Recruitment Status : Completed
First Posted : February 8, 2005
Last Update Posted : May 7, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3270 participants
Primary Purpose: Screening
Official Title: Lung Cancer Screening and Tissue Procurement
Study Start Date : February 1993
Actual Primary Completion Date : February 1994
Actual Study Completion Date : February 1994

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103363

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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)
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Principal Investigator: Timothy Kennedy University of Colorado, Denver

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Responsible Party: University of Colorado, Denver Identifier: NCT00103363    
Other Study ID Numbers: 92-0392
UCHSC-92-392 ( Other Identifier: University of Colorado Multiple Institutional Review Board )
First Posted: February 8, 2005    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014
Keywords provided by University of Colorado, Denver:
non-small cell lung cancer
small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases