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NCT Number: NCT07830576

Multimodal Survival Prediction Model for Colorectal Liver Metastases Post-Operation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230001, China

Location status: Recruiting

Location contact

can zhang

CONTACT

[email protected]

15755077865

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Multimodal Predictive Evaluation

Procedure

Observational and non-invasive assessment based on preoperative MRI-derived 3D modeling and three-dimensional lesion reconstruction, combined with clinical parameters, to build a survival prediction model. No experimental intervention is assigned.

Primary outcomes

  1. Recurrence-Free Survival (RFS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Collaborators

  • Anhui Provincial Cancer Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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