NCT06895551

Methylation Biomarkers for Pioneering Early Esophageal Cancer Detection

Prospective Multicenter Study on Early Esophageal Cancer Detection: Circulating Tumor DNA Methylation Biomarkers in Liquid Biopsy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,069 (actual)
• Sponsor: Singlera Genomics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Esophageal cancer is a highly aggressive malignancy with poor prognosis, ranking as the sixth leading cause of cancer-related deaths worldwide, particularly prevalent in regions such as East Asia and East Africa. This prospective multicenter study aims to develop and validate a blood-based DNA methylation model for the early detection of esophageal cancer and high-grade intraepithelial neoplasia (HGIN). The study will enroll 500 patients with malignant lesions, including esophageal cancer and HGIN, and 500 patients with benign lesions, including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, benign esophageal lesions, and benign gastric lesions. Through a comprehensive workflow involving methylation marker screening, model construction, training, and validation, we will identify and optimize methylation biomarkers for esophageal cancer detection. The performance of the methylation-based diagnostic model will be rigorously evaluated, including its sensitivity, specificity, and accuracy in distinguishing malignant from benign lesions. This study has the potential to establish a non-invasive, blood-based diagnostic tool for early esophageal cancer detection, which could significantly improve patient outcomes by enabling timely intervention and treatment. The results will contribute to advancing precision medicine in oncology and provide a foundation for future large-scale clinical applications.

Conditions

• Esophageal Cancer

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-05-01
• Completion: 2025-02-20
• First posted: 2025-03-26
• Last updated: 2025-04-01

Locations

1 site across 1 country: China