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NCT06842563
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
trial in Hepatocellular Carcinoma (HCC) in 900 participants. Participants enrolled and being followed up; not accepting new ones.
20 November 2025
Quick facts
| Lead sponsor | Singlera Genomics Inc. |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 900 |
| Start date | 25 February 2025 |
| Primary completion | 20 November 2025 |
| Estimated completion | 20 December 2025 |
| Sites | 1 location across China |
Conditions studied
- Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →
Sponsor
Singlera Genomics Inc.
Who can join
18 Days and older, any sex, with Hepatocellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection. The test results are compared against clinical reference standards, including pathological and/or imaging diagnoses, to assess the product's diagnostic performance. Additionally, for each gene detectable by the HepaAiQ assay, digital PCR is used as a comparator to validate analytical accuracy. The dual approach-clinical and analytical validation-supports the intended use of the test and provides sufficient clinical evidence for its registration and regulatory submission in China.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06842563
- 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.
- NCT06440018 — INSPIRE: a Multi-Cancer Early Detection Study · recruiting
- NCT06895551 — Methylation Biomarkers for Pioneering Early Esophageal Cancer Detection · completed
- 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 NCT06842563 (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: 9 July 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/NCT06842563.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing