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

ConditionsStomach NeoplasmsEndoscopyBiopsyPathology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Treatment-naive gastric cancer patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • endoscopy

    Device

    gastroscope

  • Surgery

    Procedure/Surgery

    radical gastrectomy

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: the pathology of endoscopic biopsy1 intervention
Group B: the pathology of surgical resection specimen1 intervention

Trial outcomes

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

Time frame
2-year

Secondary outcomes

1

The proportion of incomplete molecular pathology detection

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

Time frame
2-year
2

Procedure duration

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).

Time frame
2-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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