NCT03699111已完成不适用
Identification of New Patient Stratification Tools in Microsatellite Stable (MSS) RAS mt Metastatic Colorectal Cancer (mCRC) - COLOSSUS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 10
- 主要终点
- Stratification Tools
研究概览
简要总结
This is a translational, multicentre and multinational study. The aim of this study is to identify new patient stratification tools in microsatellite stable RAS mutant metastatic Colorectal Cancer
详细描述
The rational of COLOSSUS is to provide new and more effective stratification tools and therapeutic interventions, specifically tailored to MSS RAS mt mCRC patients
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
- •Patient Status
- •Ability to give signed informed consent prior to any study specific procedures and willing and able to comply with the protocol,
- •Age ≥ 18 years,
- •ECOG status of ≤ 2,
- •At least 16 weeks of life expectancy at time of entry into the study.
- •Disease-related
- •Histologically confirmed stage IV MSS RAS mt mCRC as per standard diagnostic tests,
- •Unresectable and measurable disease (at least one measurable target lesion) as per clinical and radiologic criteria (RECIST v.1.1),
- •No prior chemotherapy and/or radiation therapy for CRC administered in the metastatic setting,
- •Scheduled to receive or receiving SOC chemotherapy with fluoropyrimidines and oxaliplatin +/- bevacizumab (baseline blood sample should be collected and questionnaires completed during pre-screening and before chemotherapy initiation),
- •Availability of archival formalin-fixed paraffin-embedded (FFPE) tissue from:
- •Preferred: surgical resection of the primary or metastatic tumour
- •Biopsy samples (biopsy taken at endoscope, needle core or surgical incision or excision) obtained from the primary or metastatic tumour.
- •The archival FFPE tissue blocks must be obtained during initial diagnosis (before patient was exposed to any chemotherapy and/or radiation therapy).
排除标准
- •Patient with CRC that has received any therapy for CRC before:
- •surgical resection of tissue that would be utilised in this study
- •biopsy procedure for tissue that would be utilised in this study,
- •Patient who has received any investigational product within 28 days of the first day of palliative chemotherapy administration,
- •Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent,
- •Patient with clinical or laboratory contraindication to receive SOC chemotherapy with fluoropyrimidines and oxaliplatin.
结局指标
主要结局
Stratification Tools
时间窗: 4 years
Identification and technical (analytical) validation of new patient stratification tools (COLOSSUS subtypes) in MSS RAS mt mCRC using a novel integrative systems biomedicine multi-omics discovery framework.
次要结局
未报告次要终点
研究者
研究点 (10)
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