Colorectal Liver MetastasesNCT07830576
Multimodal Survival Prediction Model for Colorectal Liver Metastases Post-Operation
An observational study of Colorectal Liver Metastases and Colorectal Neoplasms, run by Anhui Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Liver Metastases, Colorectal Neoplasms, Liver Neoplasms
- What is being tested?
- Multimodal Predictive Evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
can zhang, 15755077865, 15755077865@163.com
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Multimodal Predictive Evaluation
- Keywords
- Colorectal Liver Metastases, Radiomics, Magnetic Resonance Imaging, Nomogram, Prognosis
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Predictive EvaluationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Multimodal Predictive Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Feb 2017
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Anhui Provincial Cancer Hospital
- Responsible party
- Principal investigator, Lianxin Liu，PhD, Anhui Provincial Hospital
- Investigators
- Jizhou Wang, MD, PhD, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830576
- Sponsor's protocol ID
- 2026KY-249
- Other IDs
- 2025AHGXZK10006
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and comply with institutional data governance policies, individual participant data from this retrospective study will not be publicly shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07830576
- Acronym / sponsor ID
- 2026KY-249
- Keywords
- Colorectal Liver Metastases, Radiomics, Magnetic Resonance Imaging, Nomogram, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- Anhui Provincial Cancer Hospital
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRLM Surgical Cohort | – | Procedure: Multimodal Predictive EvaluationA 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Predictive EvaluationObservational 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. | Procedure or surgery | CRLM Surgical Cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. To protect participant privacy and comply with institutional data governance policies, individual participant data from this retrospective study will not be publicly shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jizhou Wang, MD, PhD principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastases and Colorectal Neoplasms, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact can zhang (+8615755077865, 15755077865@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: Up to 5 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.