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This study aims to test the hypothesis that the diagnosis for histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status in gastric cancer is at least as reliable when performed on endoscopic biopsy specimens as on surgical resection specimens.
Most institutions currently diagnose gastric cancer on endoscopic biopsy specimens but use surgical resection specimens for histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status testing. However, gastric cancers treated with neoadjuvant chemoradiotherapy/chemotherapy may undergo a complete pathological response (pCR), with no residual tumors available for testing, and neoadjuvant chemoradiotherapy/chemotherapy may alter the HER-2 expression, MSI/dMMR status and EBV status of the gastric cancer in some instances. Importantly, testing histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status of gastric cancer on endoscopic biopsy material could be initiated preoperatively, allowing resultant genetic information to be used in consultation with the patient to inform treatment decisions. Therefore, the preoperative endoscopic biopsy may be a source of suitable and reliable testing material. This study aims to investigate the correlation between histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status in preoperative endoscopic biopsy specimens and their corresponding surgical resection specimens and ascertain whether endoscopic biopsy specimen is a valid and reliable testing material for determining the histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status of gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the pathology of endoscopic biopsy | The histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status of gastric cancer testing on endoscopic biopsies |
| |
| the pathology of surgical resection specimen | The histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status of gastric cancer testing on surgical resection specimens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopy | Device | gastroscope |
| |
| Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | The primary outcome of this trial is to investigate the correlation between histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status in pretreatment endoscopic biopsy specimens and their corresponding surgical resection specimens | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of incomplete molecular pathology detection | incomplete molecular pathology detection defined as endoscopic biopsy specimens and surgical resection specimens from which the definitive histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status diagnosis cannot be rendered by the pathologist | 2-year |
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Inclusion Criteria:
Exclusion Criteria:
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Treatment-naive gastric cancer patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dazhi Xu, PHD, MD | Contact | (+86) 021-38196215 | xudzh@shca.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dazhi Xu, PHD, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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preoperative endoscopic biopsy specimens and postoperative specimen of gastric tumors
| Procedure |
radical gastrectomy |
|
| Procedure duration | The total length of time for the diagnosis of histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status performed on endoscopic biopsy specimens and surgical resection specimens will be documented(days). | 2-year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |