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Novel 14 Human Papillomavirus genotyping combined with gene methylation detection for cervical cancer screening: A multi-center clinical study

Novel 14 Human Papillomavirus genotyping combined with gene methylation detection for cervical cancer screening: A multi-center clinical study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087691
Enrollment
Unknown
Registered
2024-08-01
Start date
2024-05-27
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

High grade squamous intraepithelial leasion

Interventions

Case series:None

Sponsors

The Second Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily participated in the study and signed informed consent; 2. Female patients aged =25 years old and =64 years old; 3. Abnormal cervical cytology (=AS-CUS) and/or abnormal cervical biopsy pathology within 30 days before screening; 4. No contraindications to vaginal sampling and urine sampling; 5. Willingness to collect urine, vaginal discharge and cervical exfoliated cell samples; 6. Not participating in other clinical studies within 30 days before screening.

Exclusion criteria

Exclusion criteria: 1. Previous cervical cytology > 30 days without recent results; 2. Patients received cervical physical therapy, LEEP, cervical conization, and cervical amputation due to abnormal results of cervical cancer screening before screening; 3. Patients with acute vaginal inflammation are not suitable for vaginal sampling; 4. Those who are already pregnant.

Design outcomes

Primary

MeasureTime frame
High grade squamous intraepithelial leasion;

Secondary

MeasureTime frame
HPV genotype;Gene methylation;

Countries

China

Contacts

Public ContactWuliang Wang

The Second Affiliated Hospital of Zhengzhou University

wangwuliang888@sina.com+86 371 6362 0701

Outcome results

None listed

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