Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)

Study Overview
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Brief Summary
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This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.

Detailed Description
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This is a prospective, multi-center trial conducted at 4 high-volume gastric cancer centers in China (Nanfang Hospital of Southern Medical University; Sun Yat-Sen University Cancer Center; First Affiliated Hospital, Sun Yat-Sen University; The Third Affiliated Hospital, Sun Yat-Sen University) designed to determine the predicted performance of radiomics-based prediction model for identifying metastasis of each station lymph nodes by enhanced CT for preoperative noninvasive assessment of the lymph node status in patients with gastric cancer. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.

Official Title
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Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)

Conditions
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Digestive System Diseases, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Stomach Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years; Patients providing written informed consent; Pathologically proven gastric cancer scheduled to preoperative enhanced abdomen CT and undergo gastrectomy with type D2 lymphadenectomy; Has undergone > 64 multi-detector row CT within 14 days prior to surgical resection; .No receipt of preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy). Exclusion Criteria: Preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy); Failed to receive preoperative enhanced abdomen CT or undergo gastrectomy with type D2 lymphadenectomy; Inavailable pathological results for local lymph node status; Inquality of CT images for feature extraction; .Patient quit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological lymph node status of every station | Pathological lymph node status of each station is defined as lymph node metastasis exist or not | Pathologic evaluation will be performed for each patient within 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time | Disease-free survival and overall survival | Follow-up from the date of surgery to the date of death. | 
| Lymph node stage (N stage) | Pathological lymph node stage after surgery (N0 stage: no lymph node metastassis; N1 stage: 1-2 lymph node metastasis; N2 stage: 3-6 lymph node metastasis; N3a stage: 7-15 lymph node metastasis;N3b stage: >15 lymph node metastassis) | Pathologic evaluation will be performed for each patient within 1 week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, Radiomics, Computed Tomograpy, Lymph Node Metastasis, Prediction