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临床试验/NCT00002667
NCT00002667已完成不适用

EARLY DETECTION OF SECOND PRIMARY LUNG CANCERS BY SPUTUM CYTOLOGY IMMUNOSTAINING

Eastern Cooperative Oncology Group10 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 1995年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,100
试验地点
10

研究概览

简要总结

RATIONALE: Using new methods to examine sputum samples for the presence of cancer cells may detect lung cancer earlier.

PURPOSE: Screening trial to study the effectiveness of new methods of examining sputum samples to detect second primary lung cancer in patients with resected stage I non-small cell lung cancer.

详细描述

OBJECTIVES: I. Evaluate whether immunostaining of induced sputum specimens improves the sensitivity and specificity of routine morphologic sputum surveillance to detect second primary lung cancer in patients with previously resected nonsmall cell lung cancer. II. Evaluate which patients are at risk of developing a second primary lung cancer by immunostaining specimens from patients with no morphologic atypia on routine Papanicolaou cytology. III. Make available archived sputum samples and bronchial washings for further analysis of new antibodies and techniques. IV. Evaluate whether analysis of elevations of relevant growth factors in bronchial lavage fluid from patients with positive immunostaining or morphologic atypia increases the accuracy of early detection. V. Evaluate whether quantitation of shed antigens in sputum increases the accuracy of early detection. VI. Evaluate whether the extent of airway obstruction, as measured by the forced expiratory volume, can predict an increased risk of developing lung cancer.

OUTLINE: Screening for Second Primary Lung Cancer. Annual sputum induction for Papanicolaou cytology and immunostaining (using monoclonal antibodies 624H12 and 703D4), with optional pulmonary function tests and fiberoptic bronchoscopy with bronchial washings.

PROJECTED ACCRUAL: 1,100 patients will be entered over 3 years. The sample size will be adjusted based on the rate of positive staining in the first 100 patients. Patients followed at uncertified centers are analyzed separately.

研究设计

研究类型
Interventional
主要目的
Screening

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Network
责任方
Sponsor

研究点 (10)

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