NL-OMON50622招募中不适用
Determination of new biomarkers in patients with resectable colorectal liver metastases, the MIRACLE study - MIRACLE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >= 18 years.
- •Histologically confirmed primary colorectal carcinoma.
- •Radiological confirmed and resectable liver metastasis of colorectal cancer,
- •planned to undergo resection with or without neo-adjuvant chemotherapy.
- •Before patient registration, written informed consent must be given according
- •to ICH/GCP, and national/local regulations.
排除标准
- •Prior adjuvant chemotherapy for the primary colorectal carcinoma given <6
- •months prior to detection of the liver metastases.
- •Prior non colorectal malignancies, except for patients with basal or squamous
- •cell carcinoma of the skin, or patients with carcinoma in situ of the cervix.
- •Presence of extrahepatic disease. Patients with small (<=1 cm) extrahepatic
- •lesions that are not clearly suspicious of metastases are eligible.
- •Females with a positive pregnancy test (within 14 days before treatment start).
- •History of psychiatric disability judged by the investigator to be clinically
- •significant, precluding informed consent.
- •Current or recent treatment with another investigational drug or participation
- •in another investigational study.
- •Any psychological, familial, sociological or geographical condition potentially
- •hampering compliance with the study protocol and follow-up schedule; those
- •conditions should be discussed with the patient before registration in study.
研究者
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