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Clinical validity of the human papillomavirus nucleic acid detection and 16/18 typing kit (fluorescence PCR method) for the intended use of the initial screening and combined screening of cervical cancer: a multi-center clinical trial

Clinical validity of the human papillomavirus nucleic acid detection and 16/18 typing kit (fluorescence PCR method) for the intended use of the initial screening and combined screening of cervical cancer: a multi-center clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055287
Enrollment
Unknown
Registered
2022-01-05
Start date
2017-04-01
Completion date
Unknown
Last updated
2023-01-23

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

Conditions

cervical diseases

Interventions

Gold Standard:Take colposcopy and histopathological examination results as the gold standard
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Sponsors

West China Second Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Combined screening for cervical cancer: women over the age of 30 who have no cervical intraepithelial lesions (NILM) on cervical cytology, the enrolled population is distributed in different age ranges (at least 10% between 30 and 39 years old, and 30% over 40 years old); 2. For the primary screening of cervical cancer: the results of cervical cytology test are unknown, and women over the age of 21 who are sexually active, the enrolled population is distributed in different age ranges (at least 5% =10 ml; cytological sampling is satisfactory (preparation > 5000 cells/sheet).

Exclusion criteria

Exclusion criteria: People without capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
Cytology;HPV type;Histopathological diagnosis;sensitivity, specificity, positive predictive value, negative predictive value;

Countries

China

Contacts

Public ContactXi Mingrong

West China Second Hospital of Sichuan University

qmrjzz@126.com+86 28 85501633

Outcome results

None listed

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