Novel Screening Modality for Early Gastric Cancer
- Conditions
- Gastric Cancer
- Registration Number
- NCT04114006
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for pathology analysis, per standard clinical practice.
- Detailed Description
Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for histologic analysis, with planned study of the diagnostic yields of each method.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Subject is informed of the investigational nature of this study and given verbal and written informed consent in accordance with local, U.S., and international guidelines.
- Both males and females at least 18 years.
- Patients with clinical indications for upper endoscopy
- Patients should not have an advanced medical or psychiatric conditions which that may limit their ability to participate in the study, as judged by the physician.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic yield of the WATS approach versus standard gastric biopsy mapping 1-3 Years To compare the diagnostic yield of the WATS approach versus standard gastric biopsy mapping (per the updated Sydney system).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Occidente
ðŸ‡ðŸ‡³Santa Rosa De Copán, Copan, Honduras