Cancer hospital, Chinese academy of medical sciences
Beijing, Beijing Municipality, China
NCT Number: NCT06895551
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.
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Notify Me18 year–75 year
All sexes
Observational
Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: assessed up to 36 months
Evaluate the sensitivity, specificity, and area under the curve (AUC) of the blood-based DNA methylation model in distinguishing esophageal cancer and high-grade intraepithelial neoplasia (HGIN) from benign lesions (including low-grade intraepithelial neoplasia (LGIN), submucosal esophageal cancer, and benign esophageal/gastric lesions).
Time frame: assessed up to 36 months
Assess the diagnostic performance of the methylation model across different subgroups, including early-stage esophageal cancer, advanced-stage esophageal cancer, and HGIN. Investigate the relationship between methylation levels and clinical parameters, including tumor stage (TNM I/II/III/IV), tumor differentiation grade (high/medium/low), age and gender (male/female) etc.
Singlera Genomics Inc.
Industry
Prospective Multicenter Study on Early Esophageal Cancer Detection: Circulating Tumor DNA Methylation Biomarkers in Liquid Biopsy
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