NCT00103363已完成2 期
Lung Cancer Screening and Tissue Procurement
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,270
- 试验地点
- 1
- 主要终点
- Classification of annual sputum samples cytologically
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Screening
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •25 and over
- •Performance status
- •Not specified
- •Life expectancy
- •More than 5 years
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •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
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Classification of annual sputum samples cytologically
Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
Correlation of changes in sputum cytology with lung cancer incidence
次要结局
- Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk
研究者
研究点 (1)
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