Sputum Cytology in Screening Heavy Smokers For Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00103363
First received: February 7, 2005
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 [ Designated as safety issue: No ]
  • Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence [ Designated as safety issue: No ]
  • Correlation of changes in sputum cytology with lung cancer incidence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk [ Designated as safety issue: No ]

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:

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 25 and over

Performance status

  • Not specified

Life expectancy

  • More than 5 years

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103363

Locations
United States, Colorado
University of Colorado Health Sciences Center - Denver
Denver, Colorado, United States, 80262
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Timothy Kennedy University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00103363     History of Changes
Other Study ID Numbers: 92-0392, UCHSC-92-392
Study First Received: February 7, 2005
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014