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NCT06895551
Methylation Biomarkers for Pioneering Early Esophageal Cancer Detection
trial in Esophageal Cancer in 1,069 participants. Completed in 20 February 2025.
1 May 2024
Quick facts
| Lead sponsor | Singlera Genomics Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,069 |
| Start date | 1 September 2022 |
| Primary completion | 1 May 2024 |
| Estimated completion | 20 February 2025 |
| Sites | 1 location across China |
Conditions studied
- Esophageal Cancer — all drugs for Esophageal Cancer →
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.
Verify or expand the search:
- PubMed search for NCT06895551
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Singlera Genomics Inc. trials
Trials by the same sponsor.
- NCT06842563 — Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinica · active not recruiting
- NCT06440018 — INSPIRE: a Multi-Cancer Early Detection Study · recruiting
- NCT05485077 — A Prospective Cohort Study on Colorectal Cancer Screening in Community Population · recruiting
- NCT05444491 — Application of Polygenic Methylation Markers in Postoperative Recurrence Monitoring of Colorectal Cancer · active not recruiting
- NCT05336058 — Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06895551 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Singlera Genomics Inc.
- Last refreshed: 1 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06895551.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing