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Multiplex Genotyping Detection of Human Papillomavirus

Multiplex Genotyping Detection of Human Papillomavirus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106335
Enrollment
Unknown
Registered
2025-07-22
Start date
2025-07-22
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Human Papillomavirus Infection

Interventions

Gold Standard:The HPV multiplex genotyping detection method routinely used in hospitals, namely the Hybribio HPV Genotyping Test Kit (PCR + membrane hybridization method) using cervical exfoliated cel
Index test:The Maccura HPV Genotyping Test Kit for collecting patients' cervical exfoliated cells and homologous urine.

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Gender: Female; 2. Age >= 18 years (including subjects in the age groups of =40 years); 3. One of the following populations: (1) Patients with normal cervical cytology, abnormal cervical epithelial cells, or diagnosed with cervical intraepithelial neoplasia (CIN) or cervical invasive carcinoma; (2) Patients with vaginitis, cervicitis, urethritis, or other conditions caused by other pathogens; (3) Individuals undergoing routine physical examinations; 4. Completed PCR clinical testing for HPV multiplex genotyping.

Exclusion criteria

Exclusion criteria: 1. Samples with biological contamination or obvious microbial contamination. 2.Samples repeatedly enrolled, samples unable to complete the entire testing process, or samples that cannot be traced.

Design outcomes

Primary

MeasureTime frame
HPV infection status (negative or positive and its genotyping);

Countries

China

Contacts

Public ContactBingbing Xiao

Peking University First Hospital

doctorxbb@163.com+86 135 8159 5780

Outcome results

None listed

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