NCT01531621招募中不适用
A Population-based Prospective Study to Evaluate Clinical Behaviour, Resectability and Survival in 1st Line Metastatic Colorectal Cancer (CRC) Patients in Finland
Pia Osterlund1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Resectability
研究概览
简要总结
- A population-based prospective study to evaluate clinical behaviour, resectability and survival in 1st line metastatic colorectal cancer (CRC) patients in Finland
- Primary objective: To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection
- Secondary objectives: To assess treatments for mCRC; To assess efficacy of chemotherapy and targeted drugs with overall response rates (ORR), failure free survival (FFS), progression free survival (PFS), and overall survival (OS); To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria; To evaluate whole blood, plasma, serum and tumour block biomarkers and DNA polymorphisms that may predict drug effects, resectability and clinical behaviour of the tumour
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease
- •Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy)
- •Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to study
- •No informed consent will be obtained from patients participating in the data collection study obtaining data from hospital charts. No blood sampling, nor contacting of patients will be performed.
排除标准
- 未提供
结局指标
主要结局
Resectability
时间窗: 5 years
To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection
次要结局
- Efficacy(5 years)
- Radiological assessment(5 years)
- Safety(5 years)
研究者
Pia Osterlund
Principal Investigator
Helsinki University Central Hospital
研究点 (1)
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