A Predictive Model for Recurrence of Colorectal Cancer Based on Multi-omics of Portal Vein Blood: a Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Colorectal Cancer Recurrence or Metastasis
研究概览
简要总结
This multi-center study aims to develop a precise predictive model for colorectal cancer (CRC) recurrence and metastasis based on multi-omics analysis of portal vein blood. Despite advances in surgical treatments, approximately 40% of CRC patients experience tumor recurrence or metastasis post-surgery, with 80-90% of metastases being unresectable. The study will include stage I-IV CRC patients and will be conducted in two phases: a nested case-control study and a bidirectional cohort study. Comprehensive multi-omics sequencing will be performed on samples from primary tumors, adjacent tissues, normal intestinal tissues, portal vein blood, and peripheral blood. The goal is to identify specific biomarkers in the portal vein and peripheral blood associated with CRC recurrence and metastasis, and to compare the predictive accuracy of models based on these biomarkers. The ultimate objective is to provide a more effective method for early prediction and intervention of CRC recurrence and metastasis, thereby improving patient outcomes.
Project Information:
Project Title: A predictive model for recurrence of colorectal cancer based on multi-omics of portal vein blood: a multi-center study Project Duration: January 2020 to December 2026 Lead Institution: Peking University Shougang Hospital Principal Investigator: Gu Jin Contact: Hong Haopeng, 18059211195@163.com
详细描述
- Study Title A predictive model for recurrence of colorectal cancer based on multi-omics of portal vein blood: a multi-center study
- Study Overview This multicenter study, led by Peking University Shougang Hospital, aims to develop a predictive model for the recurrence and metastasis of colorectal cancer (CRC) through multi-omics analysis of portal vein blood. The study collaborates with several prominent institutions including Peking University First Hospital, Chinese PLA General Hospital First Medical Center, Peking University Third Hospital, and Beijing Tiantan Hospital. The objective is to identify specific biomarkers indicative of CRC recurrence and metastasis, integrating these with clinical and pathological data to create highly accurate predictive models.
- Background and Rationale Colorectal cancer poses a significant health challenge in China, with high incidence and mortality rates. Despite advancements in surgical and adjuvant therapies, approximately 40% of patients undergoing radical surgery experience tumor recurrence or metachronous metastasis, with most metastatic lesions being unresectable. Predicting the risk of metachronous metastasis accurately is crucial for CRC management. This study employs advanced multi-omics techniques to analyze portal vein blood, hypothesizing that it provides comprehensive and early detection of tumor-specific genetic and epigenetic alterations compared to peripheral blood.
- Study Objectives
Primary Objective:
- Develop a predictive model for CRC recurrence and metastasis using biomarkers identified from multi-omics analysis of portal vein blood.
Secondary Objectives:
• Compare the predictive efficacy of portal vein blood versus peripheral venous blood.
• Validate the predictive models in a large, multicenter cohort.
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
- •Age 18 years or older
- •Histologically confirmed stage I-IV colorectal cancer (CRC)
- •Availability of pre-operative and intra-operative blood samples (portal vein and peripheral blood) and primary tumor tissue samples
- •No neoadjuvant therapy before surgery
排除标准
- •Prior history of other malignancies
- •Incomplete clinical information or pathology reports
- •Incomplete follow-up records
结局指标
主要结局
Colorectal Cancer Recurrence or Metastasis
时间窗: 24 months post-surgery
The primary outcome measure is the occurrence of colorectal cancer (CRC) recurrence or metastasis within 24 months post-surgery. This will be monitored through clinical evaluations, imaging studies (CT, MRI), and blood tests (CEA levels). Recurrence or metastasis will be defined by persistent elevation in CEA, and/or detection of local recurrence or distant metastases through imaging and biopsy confirmation.
次要结局
- Overall Survival(24 months post-surgery)