Sputum Cytology in Screening Heavy Smokers For Lung Cancer

Lung Cancer Screening and Tissue Procurement

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00103363

Enrollment

3270

Registered

2005-02-08

Start date

1993-02-28

Completion date

1994-02-28

Last updated

2014-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

non-small cell lung cancer, small cell lung cancer

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.

Interventions

OTHERcytology specimen collection procedure

OTHERphysiologic testing

PROCEDUREannual screening

PROCEDUREstudy of high risk factors

Study design

Primary purpose

SCREENING

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence	—
Correlation of changes in sputum cytology with lung cancer incidence	—
Classification of annual sputum samples cytologically	—

Secondary

Measure	Time frame
Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026