Last reviewed · How we verify
NCT06347887
Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection
trial testing ColonAiQ test and Colonoscopy in Colorectal Cancer in 1,965 participants. Completed in 16 January 2024.
16 January 2024
Quick facts
| Lead sponsor | Singlera Genomics Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,965 |
| Start date | 31 May 2021 |
| Primary completion | 16 January 2024 |
| Estimated completion | 16 January 2024 |
| Sites | 7 locations across China |
Drugs / interventions tested
- ColonAiQ test and Colonoscopy
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Singlera Genomics Inc.
Who can join
18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Circulating tumor DNA methylation detection as biomarker and its application in tumor liquid biopsy: advances and challenges.
Li L, Sun Y. · · 2024 · cited 52× · PMID 39525954 · DOI 10.1002/mco2.766
Verify or expand the search:
- PubMed search for NCT06347887
- 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
- 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
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 NCT06347887 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 3 June 2024
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/NCT06347887.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing