Endoscopic biopsy versus surgical specimen for molecular and pathology testing in stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational paired-sample study comparing preoperative endoscopic biopsy specimens with the corresponding surgical resection specimens from the same patients. Pathology and molecular markers compared include histological type, histological grade, LAUREN classification, HER2 expression, MSI/dMMR status, and EBV status. Eligible adults (18–75) have histologically proven primary gastric adenocarcinoma and are planned for radical R0 gastrectomy, with diagnostic biopsies collected within 12 months before enrollment. Concordance between biopsy and resection results will be measured to determine whether endoscopic samples can reliably provide the same diagnostic and molecular information as postoperative specimens.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Dazhi Xu, PHD, MD — Fudan University
• Study coordinator: Dazhi Xu, PHD, MD
• Email: xudzh@shca.org.cn
• Phone: (+86) 021-38196215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.