Skip to content

Methylation testing is used for cervical transformation zone III type detection and cervical lesion detection research.

Methylation testing is used for cervical transformation zone III type detection and cervical lesion detection research.

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092968
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-10-22
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

female reproductive system disease

Interventions

Gold Standard:HPV testing, cytology, colposcopy, histopathology
Index test:Detection of SOX1 and PAX1 gene methylation in human cervical exfoliated cells

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Adult female >=18 years old (2) Patients with abnormal HPV/TCT results and suspected type III conversion areas were observed; (3) Cervical type III transformation area was observed under colposcopy and met the LLETZ indication; (4) no history of cervical cancer surgery; (5) Patients voluntarily join the project study, sign the informed consent, and be able to comply with the examination and research procedures. (6) No sexual life, vaginal medication and irrigation within 3 days of sampling;

Exclusion criteria

Exclusion criteria: (1) Patients with insufficient cervical cell sampling or who cannot complete the sampling; (2) Patients who quit midway or cannot complete the examination process; (3) Patients with incomplete relevant test results and diagnostic information; (4) Patients who have completed colposcopy or biopsy examination in other hospitals; (5) Those who were not considered suitable for inclusion by the researchers. (6) Women in the menstrual period or pregnancy; (7) People who undergo any vaginal examination or use other similar products within two days of sampling;

Design outcomes

Primary

MeasureTime frame
sensitivity;clinical specificity;positive predictive value;negative predictive value;

Countries

China

Contacts

Public ContactZhang Dai

Peking University First Hospital

mailzhangdai@sina.com+86 139 1055 2191

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026