NCT01693861已完成不适用
Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : Effect of Chemotherapy on Cancerous Proliferation Based on the Dynamic Excretion of Urinary Nucleosides.
Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Effect of chemotherapy on urinary excretion of modified nucleosides
研究概览
简要总结
Observational, non randomized study aimed at measuring the effect of chemotherapy in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed metastatic colorectal cancer;
- •0 to 3 prior chemotherapy lines;
- •Signed informed consent;
- •Good understanding of the protocol and of the follow-up;
- •Estimated life expectancy exceeding 3 months;
- •At least one measurable metastatic lesion (RECIST criteria);
- •Performance Status (WHO) of 0 to 2;
- •Good haematological, hepatic and renal functions.
排除标准
- •More than 2 surgical resections of metastases from colorectal cancer;
- •Poor performance status (>2);
- •Poor haematological, hepatic or renal functions;
- •Uncontrolled chronic disease;
- •Serious unhealed wound, ulcer or fracture within the previous month;
- •Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
- •Pregnancy or breast-feeding during the previous month;
- •Transmeridian trip of more than 4 time zones within the prior 2 weeks;
- •Person with legal restriction to participate into clinical research, according to the current law in France.
结局指标
主要结局
Effect of chemotherapy on urinary excretion of modified nucleosides
时间窗: 17 days
1 urine sample per day 3 days before and 14 days after beginning of chemotherapy Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration 1 saliva sample : Measurement of Clock genes polymorphisms expression
次要结局
未报告次要终点
研究者
研究点 (1)
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