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NCT03961191
DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study
trial testing DNA methylation in DNA Methylation in 300 participants. Status unknown.
22 May 2020
Quick facts
| Lead sponsor | Lei Li |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 22 May 2019 |
| Primary completion | 22 May 2020 |
| Estimated completion | 22 May 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- DNA methylation
- high-risk HPV
- TCT
Conditions studied
- DNA Methylation — all drugs for DNA Methylation →
- Uterine Cervical Cancer — all drugs for Uterine Cervical Cancer →
- High Grade Squamous Intraepithelial Lesions — all drugs for High Grade Squamous Intraepithelial Lesions →
- Low Grade Squamous Intraepithelial Lesions — all drugs for Low Grade Squamous Intraepithelial Lesions →
Sponsor
Lei Li — full company profile →
Who can join
18 and older, female only, with DNA Methylation or Uterine Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results in a case-control study, so as to determine the accuracy of DNA methylation in the screening of uterine cervical lesions. This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed. The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
DNA methylation for cervical cancer screening: a training set in China.
Kong L, Wang L, Wang Z, Xiao X, et al · · 2020 · cited 32× · PMID 32576279 · DOI 10.1186/s13148-020-00885-7
Verify or expand the search:
- PubMed search for NCT03961191
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DNA methylation
Trials testing the same drug.
- NCT04220151 — Epigenetic Changes in Hepatocellular Carcinoma Developed After Direct Acting Antiviral Therapy for Chronic Hepatitis C · unknown
- NCT03960879 — DNA Methylation for Screening Uterine Cervical Lesions · unknown
Other recruiting trials for DNA Methylation
Currently open trials in the same condition.
- NCT07224854 — Epigenetic Signature for CRC Early Detection · active not recruiting
- NCT06140992 — PaCIFiC-CUP Classifies Cancer of Unknown Primary · recruiting
- NCT05737953 — Construction of Molecular Diagnostic Marker Model for Pancreatic Cystic Tumors Based on Pancreatic Cystic Fluid Samples · recruiting
- NCT06476067 — Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma · recruiting
- NCT06490003 — Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma · 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 NCT03961191 (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: 23 May 2019
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/NCT03961191.
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