NCT06152783

Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 578 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is A prospective, randomized, multicenter clinical trial: The study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. The subjects are divided into two groups by random envelopes, A and B, and the endoscopic diagnosis in different groups is performed in different order (including: White light endoscopy,CellTouch, Magnifying endoscopy with NBI(ME-NBI)). Finally, the gold standard of histopathology was used to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.The study hypothesized that the sensitivity and specificity of CellTouch in the diagnosis of early gastric cancer could reach more than 90% and more than 95%.

Detailed description

Objectives: 1\. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer. Secondary Objectives 1. Using histopathology as the gold standard, the diagnostic performance of CellTouch and ME-NBI in the diagnosis of early gastric cancer was compared and analyzed. 2. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in the diagnosis of early gastric cancer. 3. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia.

Conditions

• Early Gastric Cancer

Timeline

• Start date: 2023-11-21
• Primary completion: 2024-11-21
• Completion: 2024-11-21
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: China