RecruitingNCT04809025

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


Sponsor

Fudan University

Enrollment

510 participants

Start Date

May 24, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria6

  • 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.

Interventions

DEVICEendoscopy

gastroscope

PROCEDURESurgery

radical gastrectomy


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT04809025


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