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Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103363 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Procedure: annual screening Procedure: cytology specimen collection procedure Procedure: physiologic testing Procedure: study of high risk factors |
Phase II |
Study Type: | Interventional |
Study Design: | Screening |
Official Title: | Lung Cancer Screening and Tissue Procurement |
Study Start Date: | February 1993 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Colorado | |
University of Colorado Health Sciences Center - Denver | |
Denver, Colorado, United States, 80262 |
Principal Investigator: | Timothy Kennedy | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | CDR0000382125, UCHSC-92-392 |
Study First Received: | February 7, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00103363 |
Health Authority: | United States: Federal Government |
non-small cell lung cancer small cell lung cancer |
Thoracic Neoplasms Carcinoma, Small Cell Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |