Actively Recruiting
Comparison of Endoscopic Biopsy and Surgical Specimen for Molecular Diagnosis of Gastric Cancer
Led by Fudan University · Updated on 2025-09-29
510
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether testing for various molecular and histological features of gastric cancer, such as histological type, grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status, is as reliable on preoperative endoscopic biopsy samples as on surgical resection specimens. This is important because some gastric cancers treated before surgery may show no remaining tumor, making surgical specimens unavailable for testing. Using biopsy specimens could allow earlier genetic information to guide treatment decisions. The study compares the testing results from two sources: endoscopic biopsy specimens obtained before surgery using a gastroscope, and surgical resection specimens collected during radical gastrectomy. Both sets of samples are analyzed for the listed molecular and histological markers. The study is observational and does not involve experimental treatments but monitors and compares diagnostic accuracy and testing completeness from these two specimen types. Participants will undergo endoscopy to collect biopsy samples and then have surgery to remove the tumor for further testing. Researchers will assess the diagnostic accuracy over two years, the proportion of incomplete molecular pathology results, and procedure duration. The study involves informed consent, pathology assessments, and follows participants through the diagnostic process to understand if biopsy samples can reliably replace surgical specimens for molecular diagnosis in gastric cancer.
CONDITIONS
Brief Title
Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Histologically confirmed primary gastric adenocarcinoma
- Diagnostic biopsies collected within 12 months prior to enrollment
- Written informed consent provided
- Planned for radical R0 gastrectomy surgery
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients unable to undergo tumor resection surgery
- Serious diseases including cardiovascular, respiratory, kidney, liver diseases, uncontrolled hypertension, diabetes, mental disorders
- Poor compliance or considered unlikely to comply with study requirements
- Received anticancer drugs, biotherapy, radiotherapy, or immunotherapy within 4 weeks before or after enrollment
- History of organ transplantation, long-term immunosuppressant use, or autoimmune diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 12 months prior to enrollment
Participants undergo endoscopic biopsy to collect tissue samples for molecular testing of gastric cancer.
1 visit (in-person)
Duration - Single surgical procedure with immediate post-operative care
Participants undergo radical gastrectomy surgery to obtain surgical resection specimens for molecular testing and pathological diagnosis.
1 surgical visit and post-operative hospital stay
Duration - Up to 2 years
Participants are observed for up to 2 years to assess diagnostic accuracy and completeness of molecular pathology testing.
Periodic visits depending on clinical follow-up schedule
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
D
Dazhi Xu, PHD, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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