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Completed

NCT Number: NCT00103363

Sputum Cytology in Screening Heavy Smokers For Lung Cancer

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Health Sciences Center - Denver

Denver, Colorado, 80262, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Physiologic Testing

Other

annual screening

Procedure

study of high risk factors

Procedure

Primary outcomes

  1. Classification of annual sputum samples cytologically

  2. Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence

  3. Correlation of changes in sputum cytology with lung cancer incidence

Secondary outcomes

  1. Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Lung Cancer Screening and Tissue Procurement

Important dates

Study start
1993
Primary completion
1994
Study completion
1994
First posted
Feb 8, 2005
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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