NCT01693848已完成不适用
Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring, of Cancer Therapy: Impact of Surgical Resection of Metastasis on Urinary Excretion of Modified 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 10 人开始时间: 2012年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Effect of resection of metastasis on urinary excretion of modified nucleosides
研究概览
简要总结
Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •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 resection of metastasis on urinary excretion of modified nucleosides
时间窗: 10 days
1 Urine sample per day 3 before and 7 after surgery Measurement of modified nucleoside concentration
次要结局
- Identification of modified nucleosides as biomarkers for colorectal cancer(10 days)
研究者
研究点 (1)
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