Endoscopic biopsy versus surgical specimen for molecular and pathology testing in stomach cancer
Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer
This study will see if tissue taken by endoscopy gives the same pathology and molecular marker results as the tissue removed at surgery for adults with gastric cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 510 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04809025 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 with histologically confirmed primary gastric adenocarcinoma who have a diagnostic endoscopic biopsy (within 12 months) and are planned for radical R0 gastrectomy are ideal candidates.
Not a fit: Patients who are pregnant or lactating, unable to undergo resection, severely comorbid, immunosuppressed after transplantation, receiving recent anticancer therapy, or otherwise noncompliant are unlikely to benefit from joining this comparison.
Why it matters
Potential benefit: If biopsy samples are shown to be reliable, molecular and pathology information could be available before surgery to guide treatment choices and avoid missing data if tumors respond completely to preoperative therapy.
How similar studies have performed: Previous work shows mixed but generally moderate concordance for markers such as HER2 and MSI between biopsy and resection specimens, while comprehensive comparisons across this full panel remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.