Sputum Cytology in Screening Heavy Smokers For Lung Cancer
NCT ID: NCT00103363
Last Updated: 2014-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
3270 participants
INTERVENTIONAL
1993-02-28
1994-02-28
Brief Summary
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PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer.
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Detailed Description
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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.
Conditions
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Study Design
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SCREENING
Interventions
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cytology specimen collection procedure
physiologic testing
annual screening
study of high risk factors
Eligibility Criteria
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Inclusion Criteria
* 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
25 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Timothy Kennedy
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Health Sciences Center - Denver
Denver, Colorado, United States
Countries
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Other Identifiers
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UCHSC-92-392
Identifier Type: OTHER
Identifier Source: secondary_id
92-0392
Identifier Type: -
Identifier Source: org_study_id
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