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This is a prospective, multicenter, observational study designed to validate the predictive accuracy of a pre-developed multimodal deep learning model. The model integrates preoperative contrast-enhanced CT scans, digitized postoperative pathology images, and standard clinical data to estimate the risk of liver metastasis within two years after curative surgery in patients with stage I-III colorectal cancer.
The primary objective is to evaluate the model's performance in an independent, prospectively enrolled patient cohort. Participants will receive standard-of-care treatment according to clinical guidelines. The study involves no experimental interventions; it solely involves the collection and analysis of routinely generated clinical data. The goal is to assess the model's potential for clinical translation by providing a reliable tool for stratifying patients' risk of liver metastasis, which could inform personalized surveillance strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Validation Cohort | This single cohort consists of patients with stage I-III colorectal cancer who are prospectively enrolled after undergoing curative resection. No interventions are administered as part of this study. The cohort is used for the external validation of the pre-defined multimodal deep learning model's performance in predicting the risk of metachronous liver metastasis. All patients receive standard of care treatment and follow-up according to clinical guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Deep Learning Prediction Model | Diagnostic Test | This is a non-therapeutic, prognostic study. The intervention under investigation is the application of a pre-specified multimodal deep learning model that integrates preoperative CT imaging, digital pathology, and clinical data to stratify patients' risk of developing metachronous liver metastasis. This model functions as a prognostic tool and is not used to guide patient management in this study. Its performance is being evaluated prospectively against the actual clinical outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve (AUC) | The discriminatory performance of the pre-specified multimodal deep learning model for predicting the occurrence of metachronous liver metastasis within 2 years after curative resection. The model integrates preoperative contrast-enhanced CT, digital pathology, and clinical data. Performance is evaluated on the entire prospectively enrolled validation cohort. | 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Metastasis-Free Survival (LMFS) by Risk Group | The difference in liver metastasis-free survival between the high-risk and low-risk groups, as stratified by the model. LMFS is defined as the time from surgery to the first radiological diagnosis of liver metastasis. | From the date of surgery until the date of first documented liver metastasis or last follow-up, assessed up to 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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This study population consists of adult patients (aged 18-75) with newly diagnosed, stage I-III primary colorectal cancer who are scheduled to undergo curative resection at one of the participating clinical centers. This prospective cohort will be used for the independent validation of a pre-developed multimodal deep learning model designed to predict the risk of metachronous liver metastasis. All participants will provide informed consent prior to enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang WU, M.D. | Contact | 13636076910 | 255001907@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
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