NCT00210080已完成3 期
A Double-Blind, Placebo-Controlled, Parallel Group Study of Uridine 5'-Triphosphate (UTP) Solution for Inhalation as an Adjunct in the Diagnosis of Lung Cancer by Sputum Cytology
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 700
- 主要终点
- Proportion of lung cancers (malignancies) diagnosed by sputum cytology
研究概览
简要总结
The primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 接受健康志愿者
- 否
入选标准
- •be suspected of having primary lung cancer based upon chest radiograph(s), CT scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of malignancy
- •have FEV1 greater than or equal to 40% predicted normal for age and height
排除标准
- •have obtained a confirmed diagnosis for the current suspicious lung tumor
- •have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening
- •have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing
结局指标
主要结局
Proportion of lung cancers (malignancies) diagnosed by sputum cytology
次要结局
- Wet weight of sputum expectorated;
- Proportion of small and large lung cancers diagnosed by sputum cytology;
- Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
- Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
- Macrophage content of sputum
研究者
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