A Prospective, Multicenter, Observational Registry of Metastatic Colorectal cancer (mCRC) Disease to determine Demographics, Clinical features, Molecularfeatures and Treatment outcomes in patients undergoing treatment at participating centers.
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
- 15
- 主要终点
- To understand the clinical profile (e.g. Baseline demographics, Clinical presentations, co-morbid conditions, Performance
研究概览
简要总结
This study is an multicenter, prospective Observational Registry study to determine Demographics, Clinical features, Molecular features and Treatment outcomes in patients undergoing treatment at participating centers who are ≥18 years that will be conducted in India. The objectives will be to understand the clinical profile, tumour characteristics, current treatment pattern of Metastatic Colorectal cancer (mCRC) patients and the outcomes in Metastatic Colorectal cancer (mCRC) patients undergoing treatment. Up to 1000 participants with Metastatic Colorectal Cancer to be enrolled in the Registry from up to 15 centres over a period of 2 years.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •ï‚· Metastatic adenocarcinoma of colon or rectum ï‚· Inoperable and eligible for first line systemic therapy ï‚· Age ≥ 18yrs.
- •ï‚· Signed informed consent.
排除标准
- •ï‚· Any participants who received his or her treatment at participating study sites prior to enrolment except for patients with metachronous mCRC ï‚· Non-metastatic Colorectal cancer.
结局指标
主要结局
To understand the clinical profile (e.g. Baseline demographics, Clinical presentations, co-morbid conditions, Performance
时间窗: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
status etc.) of Metastatic Colorectal cancer (mCRC) patients undergoing treatment
时间窗: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
ï‚· To understand the tumour characteristics (tumour location, Site of metastasis, Number of metastatic sites, Molecular profile [KRAS including KRAS G12C, BRAF, MSI/MSS, HER2 etc) of Metastatic Colorectal cancer (mCRC) patients undergoing
时间窗: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
treatment.
时间窗: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
ï‚· To understand the current treatment pattern of Metastatic Colorectal cancer (mCRC) patients
时间窗: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
ï‚· To understand Treatment outcomes in Metastatic Colorectal cancer (mCRC) patients undergoing treatment
时间窗: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
次要结局
未报告次要终点