NCT04809025 Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer
| NCT ID | NCT04809025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Stomach Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 510 participants |
| Start Date | 2021-05-24 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 510 participants in total. It began in 2021-05-24 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Dazhi Xu, PHD, MD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT04809025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stomach Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04809025 currently recruiting?
Yes, NCT04809025 is actively recruiting participants. Contact the research team at xudzh@shca.org.cn for enrollment information.
Where is the NCT04809025 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04809025 clinical trial?
NCT04809025 is sponsored by Fudan University. The principal investigator is Dazhi Xu, PHD, MD at Fudan University. The trial plans to enroll 510 participants.