A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Number of retrospectively recruited CRC cases
研究概览
简要总结
ALFAOMEGA-RETRÒ will be exploited to retrospectively collect clinical and imaging data and archival samples to be used for validation and correlative studies on markers discovered by cutting-edge translational projects within the AIRC5x1000 program "Insights into the evolving heterogeneity of colorectal cancer (CRC): from mechanism to therapies" (an ongoing multi-institutional research program).
详细描述
ALFAOMEGA-RETRÒ, the retrospective "mirror" protocol of ALFAOMEGA (protocol n. IFOM-CPO003/2018/PO002), has been designed to build a retrospective collection of clinically annotated data and biological samples retrieved from colorectal cancer patients (CRC).
The repository will feed experimental precision research aimed at i) defining a new taxonomy of CRC based on evolutionary patterns (retrospectively assessed on patient's samples), ii) developing and evaluating innovative biomarker-specific therapeutic strategies derived from or together with ALFAOMEGA.
The following data and biological samples will be collected:
- Clinical Data (Demographics, Medical History, Cancer Diagnosis & History, Treatment Assessment,).
- Imaging Data (CT-Scans, MRI, PET...).
- Formalin-Fixed Paraffin-Embedded (FFPE) tissue (either from surgical resections or diagnostic biopsies).
- Frozen biological samples (blood, plasma, PBMC, stools, buccal swabs, urines, etc.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 diagnosis of colorectal cancer (any stage).
- •Age >18 years at the time of diagnosis.
- •Availability of clinically-annotated radio-imaging data and/or diagnostic Formalin-Fixed Paraffin Embedded (FFPE) blocks (surgical resections and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides.
- •Verification that the patient could not be reached for informed consent in accordance with applicable national regulations.
排除标准
- •if inclusion criteria are not met
结局指标
主要结局
Number of retrospectively recruited CRC cases
时间窗: 6 months
Number of retrospectively recruited CRC cases with complete matched clinical data, radio-imaging data and FFPE or frozen biological samples.
次要结局
未报告次要终点