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| ID | Type | Description | Link |
|---|---|---|---|
| 82360112 | Other Grant/Funding Number | the National Natural Science Foundation of China | |
| 2024A0032 | Other Grant/Funding Number | Jiangxi Provincial Traditional Chinese Medicine Administration Science and Technology Plan |
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The goal of this dual-center study is to identify the most valuable predictive factors (MVPs) for non-curable mixed-type early gastric cancer (NC-MTEGC) and develop a nomogram scoring model to assist surgeons in formulating precise postoperative combined radiochemotherapy strategies in patients with mixed-type early gastric cancer (MTEGC) who have undergone radical surgical resection. The main question it aims to answer is:
What are the most valuable predictive factors for NC-MTEGC, and can a nomogram scoring model developed based on these factors effectively assist in formulating precise postoperative combined radiochemotherapy strategies?
Patients with MTEGC who have undergone radical surgical resection (including 160 in the training group, 151 in the internal validation set from the First Affiliated Hospital of Nanchang University, and 110 in the external test cohort from the Second Affiliated Hospital of Nanchang University) will be included in the study. The Least Absolute Shrinkage and Selection Operator (LASSO) algorithm will be used to assess key predictive indicators, a nomogram prediction model will be developed based on logistic regression, and an NC-MTEGC risk score model will be constructed. Meanwhile, the model's discriminatory ability, calibration, and clinical utility will be comprehensively validated across the three cohorts, with follow-up for relevant conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A training set | The patients with early gastric cancer (EGC) who underwent radical gastrectomy at the Donghu Ward of the First Affiliated Hospital of Nanchang University | ||
| A internal validation set | The patients with early gastric cancer (EGC) who underwent radical gastrectomy at the Xianghu Ward of the First Affiliated Hospital of Nanchang University | ||
| A external validation set | The patients with early gastric cancer (EGC) who underwent radical gastrectomy of the Second Affiliated Hospital of Nanchang University |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer | Evaluate the incidence of adverse postoperative prognosis in patients with mixed-type early gastric cancer via the Nomogram model scoring. | From enrollment to the end of treatment at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological malignancy grade | Grading criteria refer to clinical guidelines: High risk, Medium risk, Low risk. | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Lymph node metastasis detected by CT | The status of lymph node metastasis is divided into "no lymph node metastasis (no tumor cell invasion of lymph nodes detected)" and "lymph node metastasis (the presence of tumor cell invasion of lymph nodes)". | From enrollment to the end of treatment at 5 years |
| Tumor lesion long diameter |
Inclusion Criteria:
Exclusion Criteria:
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mixed-type early gastric cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
The secure sharing of Individual Participant Data (IPD) must adhere to the principles of "privacy protection first, minimum necessity, and full-process controllability". It should integrate technical safeguards (such as de-identification and encryption), management norms (including access control and protocol constraints), and compliance reviews. This approach aims to promote collaboration in medical research while maximizing the protection of participants' rights and interests.
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Measured and reported in millimeters (mm) |
| Periprocedural |
| Ulcer long diameter | Measured and reported in millimeters (mm) | Periprocedural |
| T stage | Staging criteria refer to clinical guidelines | Periprocedural |
| Gender | Binary classification, divided into male and female | Baseline |
| Ki67 expression level | Measured and reported as a percentage (%) | Periprocedural |
| P53 expression level | Measured and reported as a percentage (%) | Periprocedural |
| Lesion location | The lesion locations are classified as follows: Gastric Body, Gastric Antrum, Gastric Angle, Cardia, Pylorus, and Antrum-Body Junction. | Periprocedural |
| CEA level | Measured and reported in nanograms per milliliter (ng/mL) | Baseline |