A Multi-Centered Trial Evaluating the Role of Vitamin D Metabolism in Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Time to lung cancer related death
研究概览
简要总结
Vitamin D exerts antiproliferative and differentiating effects in cancers, including non-small cell lung cancer (NSCLC). The active form of Vitamin D is 1,25, dihydroxycholecalciferol (calcitriol) which rapidly induces expression of cytochrome P450 24R-hydroxylase (CYP24A1). CYP24A1 initiates inactivation of calcitriol as a result of successive hydroxylation/oxidation reactions. This study seeks to prospectively determine the relationship between Vitamin D gene expression and median survival as a primary outcome, and between the Vitamin D receptor (VDR)/CYP24A1 gene expression and cancer stage, smoking status, serum 1,25 (OH)2D3 levels as well as CYP24A1 genotype.
详细描述
This study seeks to prospectively determine the relationship between Vitamin D gene expression and median survival as a primary outcome, and the relationships between the Vitamin D receptor (VDR)/CYP24A1 gene expression and cancer stage, smoking status, serum 1,25 (OH)2D3 levels as well as CYP24A1 genotype.
Patients who are suspected to have lung cancer will be recruited to this study prior to their diagnostic biopsy. Those who have consented to the study will give permission for blood and tissue from this biopsy to be analyzed for the study endpoints. Statistical analysis on this data will seek to correlate CYP24A1 expression and medican survival of the participants. Patients' data will be collected for smoking status and cancer stage.
Study enrollment to adequately power the study statistically is 80 patients. Anticipated study duration is from 12 months to 18 months for sample collection and two years for follow-up for patient survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for diagnostic bronchoscopy for suspected advanced stage lung cancer by CT/PET scanning.
- •Tumor or lymph node accessible by transbronchial needle aspiration.
- •All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines.
排除标准
- •Unstable cardiovascular disease or other systemic disease
- •Mental incompetence/active psychiatric illness
- •Medical contraindication for bronchoscopy
结局指标
主要结局
Time to lung cancer related death
时间窗: 18 months
Time to lung cancer related death
次要结局
未报告次要终点