Last reviewed · How we verify
NCT04646954
DNA Methylation Testing for the Screening of Uterine Cervical Lesion
Phase 3 trial testing Host DNA methylation testing in Cervical Cancer in 12,000 participants. Status unknown.
26 November 2022
Quick facts
| Lead sponsor | Lei Li |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 12,000 |
| Start date | 26 November 2020 |
| Primary completion | 26 November 2022 |
| Estimated completion | 26 November 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Host DNA methylation testing
- Cervical cytology and/or high-risk human papillomavirus assays
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
- Cervical Intraepithelial Neoplasia — all drugs for Cervical Intraepithelial Neoplasia →
- DNA Methylation — all drugs for DNA Methylation →
- High-risk Human Papillomavirus — all drugs for High-risk Human Papillomavirus →
Sponsor
Lei Li — full company profile →
Who can join
21 and older, female only, with Cervical Cancer or Cervical Intraepithelial Neoplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Triage performance of PAX1<sup>m</sup>/JAM3<sup>m</sup> in opportunistic cervical cancer screening of non‒16/18 human papillomavirus-positive women: a multicenter prospective study in China.
Chen X, Jin X, Kong L, Liou Y, et al · · 2024 · cited 6× · PMID 39152491 · DOI 10.1186/s13148-024-01731-w -
The triage role of cytological DNA methylation in women with non-16/18, specifically genotyping high-risk HPV infection.
Su H, Jin X, Kong L, You Y, et al · · 2025 · cited 5× · PMID 40204948 · DOI 10.1038/s41416-025-03005-5 -
Cytologic DNA methylation for managing minimally abnormal cervical cancer screening results.
Shang X, Kong L, You Y, Wu H, et al · · 2025 · cited 4× · PMID 40238123 · DOI 10.1002/ijgo.70167 -
Triage performance of DNA methylation for women with high-risk human papillomavirus infection.
Kong L, Xiao X, Wu H, You Y, et al · · 2025 · cited 2× · PMID 39603822 · DOI 10.1093/oncolo/oyae324
Verify or expand the search:
- PubMed search for NCT04646954
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cervical Cancer
Currently open trials in the same condition.
- NCT07276360 — Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda · Phase 2 · recruiting
- NCT05570422 — A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 · Phase 1 · recruiting
- NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
- NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
- NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting
Other Lei Li trials
Trials by the same sponsor.
- NCT06558019 — Exosome-based OCS Scores for Predicting Ovarian Cancer Recurrence · not yet recruiting
- NCT06557954 — Cervical Cytology DNA Methylation for Cervical Cancer Screening · not yet recruiting
- NCT05801263 — ctDNA Methylation for Epithelial Ovarian Cancer · unknown
- NCT05801276 — ctDNA Methylation for Detecting Ovarian Cancer · unknown
- NCT06490380 — HRD Status Reference Standard Based on WGS · 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 NCT04646954 (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 Lei Li
- Last refreshed: 30 November 2020
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/NCT04646954.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing