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NCT Number: NCT04809025

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

yu zhang, MD,PHD

CONTACT

[email protected]

(+86) 021-38196215

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Endoscopy

Device

gastroscope

Surgery

Procedure

radical gastrectomy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dazhi Xu, PHD, MD

CONTACT

[email protected]

(+86) 021-38196215

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Acronym: EBPS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2021
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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