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

Stomach Neoplasms Clinical Trial

— EBPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809025
• Other study ID #: EBPS
• Status: Recruiting
• Start date: May 24, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: December 2021
• Source: Fudan University
• Contact: Dazhi Xu, PHD, MD
• Phone: (+86) 021-38196215
• Email: xudzh[@]shca.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biopsy
• Endoscopy
• Pathology
• Stomach Neoplasms

Intervention

Device:
• endoscopy
gastroscope

Procedure:
• Surgery
radical gastrectomy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2-year
Secondary	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).	2-year