Stomach Neoplasms Clinical Trial
— EBPSOfficial title:
Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer
NCT number | NCT04809025 |
Other study ID # | EBPS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 24, 2021 |
Est. completion date | April 1, 2024 |
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.
Status | Recruiting |
Enrollment | 510 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Lower age limit of research subjects 18 years old and upper age limit of 75 years old. 2. Histologically proven primary gastric adenocarcinoma (Diagnostic biopsies must be collected within 12 months prior to enrollment). 3. Written informed consent from the patient. 4. Patients planned for radical R0 gastrectomy. Exclusion Criteria: 1. Female in pregnancy or lactation. 2. Patients with gastric cancer who can not undergo tumor resection 3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases. 4. Patients with poor compliance or considered to be poor compliance. 5. Patients received any anticancer drugs, biotherapy, radiotherapy or immunotherapy within 4 weeks before or after enrollment. 6. Patients after organ transplantation, long-term need to take immunosuppressants, autoimmune diseases. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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