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Clinical study on the efficacy of HPV E6/E7 protein in detecting cervical lesions

Clinical study on the efficacy of HPV E6/E7 protein in detecting cervical lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113200
Enrollment
Unknown
Registered
2025-11-26
Start date
2023-10-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Cervical lesions

Interventions

Index test:HPV E6/E7 oncoprotein

Sponsors

Beijing Maternity Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age >=18 years old, female (2) Have a history of sexual life and exposure to HPV; (3) Meet the indications for colposcopy referral as indicated in the guidelines; (4) No previous history of cervical lesions; (5) No previous history of endometrial lesions; (6) No concurrent cancer; (7) Not in a pregnant state and having no pregnancy plans during the enrollment period.

Exclusion criteria

Exclusion criteria: (1) Unable to provide medical history information; (2) Other malignant tumors of the female reproductive system; (3) Sexual activity, vaginal bleeding, vaginal irrigation or vaginal medication within 48 hours before sampling; (4) Previous history of cervical surgery, including leep or conization, etc. (5) Acute infections of the reproductive tract and urinary system.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive predictive value;Negative predictive value;Missed diagnosis rate;Misdiagnosis rate;Likelihood ratio;

Countries

China

Contacts

Public ContactJinwei Miao

Beijing Maternity Hospital affiliated to Capital Medical University

jinweimiao@ccmu.edu.cn+86 10 8598 5110

Outcome results

None listed

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