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临床试验/NCT07830576
NCT07830576招募中不适用

Construction of a Post-operative Multimodal Survival Prediction Model for Patients With Colorectal Liver Metastases: A Study Based on the Fusion of a Multicenter Cohort and High-dimensional Radiomics

Anhui Provincial Hospital1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
205
试验地点
1
主要终点
Recurrence-Free Survival (RFS)

研究概览

简要总结

The purpose of this study is to construct and validate a multimodal survival prediction model by integrating 3D radiomics features derived from preoperative magnetic resonance imaging (MRI) with systemic clinical baseline indicators for patients with colorectal liver metastases (CRLM) after surgery. By combining micro-level radiomics signatures reflecting tumor micro-heterogeneity with macro-level clinical parameters (such as liver function and tumor biomarkers), the study aims to accurately evaluate individual post-operative prognostic risks. This quantitative tool will provide reliable decision support for clinicians to customize post-operative follow-up and personalized adjuvant treatment strategies.

详细描述

This study is based on a strictly screened multicenter cohort of patients with colorectal liver metastases who underwent surgical intervention. First, high-throughput quantitative features are automatically extracted from the 3D regions of interest (ROIs) segmented based on pre-operative magnetic resonance imaging (MRI). Advanced machine learning dimensionality reduction algorithms are subsequently applied to eliminate redundant variables and select core imaging signatures that deeply reflect tumor micro-heterogeneity, microvascular proliferation, and invasive status. On this basis, these micro-level radiomics features are fused with macro-level clinical parameters, including liver function indexes and tumor load markers. Multivariable survival analysis models are performed to identify independent prognostic factors, which are further used to develop a visual and intuitive predictive nomogram tool. Finally, time-dependent evaluation metrics and an external validation cohort will be utilized to systematically test the dynamic predictive performance and cross-platform generalizability of the model. This multimodal dual-track data paradigm aims to achieve a non-invasive and efficient "digital optical biopsy" approach for prognostic evaluation.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 18 years old. Confirmed diagnosis of colorectal cancer with liver metastases (CRLM). Underwent surgical resection for colorectal liver metastases. Preoperative liver magnetic resonance imaging (MRI) was performed with high-quality images available for 3D radiomics feature extraction.
  • Complete baseline clinical, laboratory, and post-operative follow-up survival data.

排除标准

  • Patients who received local ablation only (such as radiofrequency ablation) without surgical resection.
  • Preoperative MRI images with severe artifacts or poor quality that prevent high-throughput radiomics analysis.
  • Concurrent history of other primary malignant neoplasms. Missing key clinical variables or lost to follow-up immediately after surgical intervention.

研究组 & 干预措施

CRLM Surgical Cohort

A multicenter cohort consisting of patients with colorectal liver metastases who underwent surgical resection. Preoperative magnetic resonance imaging (MRI) is utilized for 3D modeling and three-dimensional reconstruction of the liver and lesions, from which key spatial/morphological features and systemic clinical parameters are analyzed to predict post-operative recurrence-free survival.

干预措施: Multimodal Predictive Evaluation (Procedure)

结局指标

主要结局

Recurrence-Free Survival (RFS)

时间窗: Up to 5 years post-surgery

Recurrence-free survival (RFS) is defined as the time from the date of surgical resection to the date of first tumor recurrence (local, regional, or distant) or death from any cause, whichever occurs first.

次要结局

未报告次要终点

研究者

发起方
Anhui Provincial Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Lianxin Liu,PhD

Professor

Anhui Provincial Hospital

研究点 (1)

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