Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 3
- 主要终点
- PheT:HOPhe ratio
研究概览
简要总结
This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk for lung cancer. Studying samples of urine in the laboratory from smokers who are at high risk for lung cancer may help doctors learn more about biomarkers related to cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the relationship between urinary deuterated ([D10]) phenanthrene tetraol (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell Park Cancer Institute (RPCI).
OUTLINE:
Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for laboratory studies for 6 hours after dosing.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
干预措施: deuterated phenanthrene tetraol (Drug)
Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
干预措施: pharmacological study (Drug)
Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing.
干预措施: laboratory biomarker analysis (Drug)
结局指标
主要结局
PheT:HOPhe ratio
时间窗: Up to 6 hours
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia
时间窗: Up to 6 hours
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
Urinary deuterated phenanthrene tetraol level
时间窗: Up to 6 hours
A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of chronic obstructive pulmonary disease (COPD) or asbestos, duration of smoking, smoking intensity, age, and gender.
次要结局
未报告次要终点