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NCT05558436
Comparison of Diagnostic Sensitivity Between ctDNA Methylation and CEA in Colorectal Cancer
trial testing Genome-wide methylation profiling in Colorectal Tumor in 662 participants. Participants enrolled and being followed up; not accepting new ones.
1 May 2024
Quick facts
| Lead sponsor | Nanfang Hospital, Southern Medical University |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 662 |
| Start date | 1 June 2022 |
| Primary completion | 1 May 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Genome-wide methylation profiling
Conditions studied
- Colorectal Tumor — all drugs for Colorectal Tumor →
Sponsor
Nanfang Hospital, Southern Medical University
Who can join
Adults 18 to 80, any sex, with Colorectal Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective diagnostic study. This study is to compare the performance between circulating tumor DNA (ctDNA) methylation and carcinoembryonic antigen (CEA) in detecting colorectal tumor. Firstly, based on the identification of differential ctDNA methylation biomarkers, the diagnostic model is established and the diagnostic performance was compared with that of CEA. Secondly, the stage stratification model was established preliminarily based on differential ctDNA methylation biomarkers and the performance was also compared with that of CEA.
Publications & conference data
4 peer-reviewed publications 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 -
Current Applications of Liquid Biopsy in Gastrointestinal Cancer Disease-From Early Cancer Detection to Individualized Cancer Treatment.
David P, Mittelstädt A, Kouhestani D, Anthuber A, et al · · 2023 · cited 10× · PMID 37046585 · DOI 10.3390/cancers15071924 -
Circulating tumor DNA methylation-based method for noninvasive detection and stage stratification of colorectal tumor.
Ji H, Xu M, Jiang W, Hu Y, et al · · 2026 · PMID 41796341 · DOI 10.1186/s13148-026-02097-x -
Preoperative Identification of Lymph Node Metastasis in Colorectal Cancer Using Noninvasive Circulating Tumor DNA Methylation Signatures: Results From a Prospective Study.
Ji H, Xu M, Hu Y, Yan B, et al · · 2026 · PMID 41378988 · DOI 10.1097/dcr.0000000000004089
Verify or expand the search:
- PubMed search for NCT05558436
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Nanfang Hospital, Southern Medical University trials
Trials by the same sponsor.
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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 NCT05558436 (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 Nanfang Hospital, Southern Medical University
- Last refreshed: 10 May 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/NCT05558436.
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