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

September 24, 2025 updated by: Dazhi Xu, Fudan University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Most institutions currently diagnose gastric cancer on endoscopic biopsy specimens but use surgical resection specimens for histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status testing. However, gastric cancers treated with neoadjuvant chemoradiotherapy/chemotherapy may undergo a complete pathological response (pCR), with no residual tumors available for testing, and neoadjuvant chemoradiotherapy/chemotherapy may alter the HER-2 expression, MSI/dMMR status and EBV status of the gastric cancer in some instances. Importantly, testing histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status of gastric cancer on endoscopic biopsy material could be initiated preoperatively, allowing resultant genetic information to be used in consultation with the patient to inform treatment decisions. Therefore, the preoperative endoscopic biopsy may be a source of suitable and reliable testing material. This study aims to investigate the correlation between histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status in preoperative endoscopic biopsy specimens and their corresponding surgical resection specimens and ascertain whether endoscopic biopsy specimen is a valid and reliable testing material for determining the histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status and EBV status of gastric cancer.

Study Type

Observational

Enrollment (Estimated)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Treatment-naive gastric cancer patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
gastroscope
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
radical gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: 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
2-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of incomplete molecular pathology detection
Time Frame: 2-year
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
Procedure duration
Time Frame: 2-year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Dazhi Xu, PHD, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBPS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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