Sputum Cytology in Screening Heavy Smokers For Lung Cancer

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT00103363

First received: February 7, 2005

Last updated: February 26, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2005

Last Updated Date

February 26, 2013

Start Date ^ICMJE

February 1993

Primary Completion Date

February 1994 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00103363 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Sputum Cytology in Screening Heavy Smokers For Lung Cancer

Official Title ^ICMJE

Lung Cancer Screening and Tissue Procurement

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Screening

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

February 1994

Primary Completion Date

February 1994 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00103363

Other Study ID Numbers ^ICMJE

92-0392, UCHSC-92-392

Has Data Monitoring Committee

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Timothy Kennedy

University of Colorado, Denver

Information Provided By

University of Colorado, Denver

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top