Clinical trial · Observational
Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer
NCT04809025CI-TRIAL-00095913EBPSrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biopsy | — | UNRESOLVED | — |
| Endoscopy | — | UNRESOLVED | — |
| Pathology | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopy | Device | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- the pathology of endoscopic biopsy
- description
- The histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status of gastric cancer testing on endoscopic biopsies
- interventionNames
- Device: endoscopy
- label
- the pathology of surgical resection specimen
- description
- The histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status of gastric cancer testing on surgical resection specimens
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- 2-year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.