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

NCT04809025 | Recruiting DMC

• 1 other identifier: EBPS
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stomach Neoplasms; Endoscopy; Biopsy; Pathology

Keywords

Stomach Neoplasms; Endoscopy; Biopsy; Pathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The proportion of incomplete molecular pathology detection

  2-year

• Procedure duration

  2-year

Study Arms (2)

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

Device: endoscopy

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

Procedure: Surgery

Interventions

endoscopy DEVICE

gastroscope

the pathology of endoscopic biopsy

Surgery PROCEDURE

radical gastrectomy

the pathology of surgical resection specimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Treatment-naive gastric cancer patients

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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

preoperative endoscopic biopsy specimens and postoperative specimen of gastric tumors

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Officials

• Dazhi Xu, PHD, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dazhi Xu, PHD, MD

CONTACT

(+86) 021-38196215; xudzh@shca.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 22, 2021
• Study Start: May 24, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

CN (1)