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NCT06895551

Methylation Biomarkers for Pioneering Early Esophageal Cancer Detection

Completed Last updated 1 April 2025
What this trial tests

trial in Esophageal Cancer in 1,069 participants. Completed in 20 February 2025.

Timeline
1 September 2022
Primary endpoint
1 May 2024
20 February 2025

Quick facts

Lead sponsorSinglera Genomics Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,069
Start date1 September 2022
Primary completion1 May 2024
Estimated completion20 February 2025
Sites1 location across China

Conditions studied

Sponsor

Singlera Genomics Inc.

Who can join

Adults 18 to 75, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Esophageal Cancer

Currently open trials in the same condition.

Other Singlera Genomics Inc. trials

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