Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer

Recruiting now

Conditions studied: Stomach Neoplasms, Endoscopy, Biopsy, Pathology

In brief

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.

Key facts

Study ID

NCT04809025

Run by

Fudan University

People needed

510

Starts

2021-05-24

Expected to finish

2026-09-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
• Histologically proven primary gastric adenocarcinoma (Diagnostic biopsies must be collected within 12 months prior to enrollment).
• Written informed consent from the patient.
• Patients planned for radical R0 gastrectomy.

You may not qualify if…

• Female in pregnancy or lactation.
• Patients with gastric cancer who can not undergo tumor resection
• Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
• Patients with poor compliance or considered to be poor compliance.
• Patients received any anticancer drugs, biotherapy, radiotherapy or immunotherapy within 4 weeks before or after enrollment.
• Patients after organ transplantation, long-term need to take immunosuppressants, autoimmune diseases.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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