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Recruiting Observational

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

NCT04809025 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2021-05-24
Last updated
2025-09-29

Condition(s) studied

Stomach NeoplasmsEndoscopyBiopsyPathology

Investigational drug(s) / intervention(s)

endoscopySurgery

endoscopy: gastroscope

Surgery: radical gastrectomy

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Diagnostic accuracy — 2-year
    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

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04809025 on ClinicalTrials.gov ↗ ← All trials in China