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Sputum Cytology in Screening Heavy Smokers For Lung Cancer

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT00103363
Collaborator
National Cancer Institute (NCI) (NIH)
3,270
Enrollment
1
Location
12
Duration (Months)
272.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: cytology specimen collection procedure
  • Other: physiologic testing
  • Procedure: annual screening
  • Procedure: study of high risk factors
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
3270 participants
Primary Purpose:
Screening
Official Title:
Lung Cancer Screening and Tissue Procurement
Study Start Date :
Feb 1, 1993
Actual Primary Completion Date :
Feb 1, 1994
Actual Study Completion Date :
Feb 1, 1994

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Colorado Health Sciences Center - Denver Denver Colorado United States 80262

Sponsors and Collaborators

  • University of Colorado, Denver
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Timothy Kennedy, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00103363
Other Study ID Numbers:
  • 92-0392
  • UCHSC-92-392
First Posted:
Feb 8, 2005
Last Update Posted:
May 7, 2014
Last Verified:
May 1, 2014
Keywords provided by University of Colorado, Denver
non-small cell lung cancer
small cell lung cancer
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of May 7, 2014