Trials / Recruiting
RecruitingNCT04809025
Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 510 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- —
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | endoscopy | gastroscope |
| PROCEDURE | Surgery | radical gastrectomy |
Timeline
- Start date
- 2021-05-24
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2021-03-22
- Last updated
- 2025-09-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04809025. Inclusion in this directory is not an endorsement.