Sputum Cytology in Screening Heavy Smokers For Lung Cancer

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00103363

UCHSC-92-392 (Other Identifier)

92-0392

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,270 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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