Sputum Cytology in Screening Heavy Smokers For Lung Cancer

Lung Cancer Clinical Trial

Official title:

Lung Cancer Screening and Tissue Procurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103363
• Other study ID #: 92-0392
• Secondary ID: UCHSC-92-392
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2005
• Last updated: May 5, 2014
• Start date: February 1993
• Est. completion date: February 1994

Study information

• Verified date: May 2014
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3270
• Est. completion date: February 1994
• Est. primary completion date: February 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• cytology specimen collection procedure

• physiologic testing

Procedure:
• annual screening

• study of high risk factors

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center - Denver	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of annual sputum samples cytologically			No
Primary	Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence			No
Primary	Correlation of changes in sputum cytology with lung cancer incidence			No
Secondary	Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk			No