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Sputum Cytology in Screening Heavy Smokers For Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cytology specimen collection procedure
physiologic testing
annual screening
study of high risk factors
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring non-small cell lung cancer, small cell lung cancer

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Health Sciences Center - Denver

Outcomes

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

Full Information

First Posted
February 7, 2005
Last Updated
May 5, 2014
Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00103363
Brief Title
Sputum Cytology in Screening Heavy Smokers For Lung Cancer
Official Title
Lung Cancer Screening and Tissue Procurement
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 1993 (undefined)
Primary Completion Date
February 1994 (Actual)
Study Completion Date
February 1994 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
non-small cell lung cancer, small cell lung cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Enrollment
3270 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
cytology specimen collection procedure
Intervention Type
Other
Intervention Name(s)
physiologic testing
Intervention Type
Procedure
Intervention Name(s)
annual screening
Intervention Type
Procedure
Intervention Name(s)
study of high risk factors
Primary Outcome Measure Information:
Title
Classification of annual sputum samples cytologically
Title
Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
Title
Correlation of changes in sputum cytology with lung cancer incidence
Secondary Outcome Measure Information:
Title
Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Kennedy
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States

12. IPD Sharing Statement

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Sputum Cytology in Screening Heavy Smokers For Lung Cancer

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