NCT07830576

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

9.6 years

First QC Date

July 31, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

Colorectal Liver MetastasesRadiomicsMagnetic Resonance ImagingNomogramPrognosis

Outcome Measures

Primary Outcomes (1)

  • Recurrence-Free Survival (RFS)

    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.

    Up to 5 years post-surgery

Study Arms (1)

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.

Procedure: Multimodal Predictive Evaluation

Interventions

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.

CRLM Surgical Cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients diagnosed with colorectal liver metastases who underwent surgical resection across multiple participating clinical centers, featuring high-quality preoperative liver MRI scans and complete clinical follow-up histories.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsLiver Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver Diseases

Study Officials

  • Jizhou Wang, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2026

First Posted

September 21, 2026

Study Start

February 1, 2017

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

To protect participant privacy and comply with institutional data governance policies, individual participant data from this retrospective study will not be publicly shared.

Locations