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A study to assess the accuracy, sensitivity, and generalisability of self-sampling versus physician sampling in nucleic acid testing for human papillomavirus infection

A study to assess the accuracy, sensitivity, and generalisability of self-sampling versus physician sampling in nucleic acid testing for human papillomavirus infection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100121
Enrollment
Unknown
Registered
2025-04-02
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

HPV infection

Interventions

Gold Standard:Cervical decidual cell HPV nucleic acid test
Index test:Self-sampling cervical exfoliative cell HPV nucleic acid test

Sponsors

Shanghai East Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Meets diagnostic criteria for vaginitis or cervicitis; 2.Baseline cytology (TCT) or cervical colposcopy results to rule out CIN and carcinoma; 3.Patient is no less than 18 years of age and has a history of sexual activity; 4.No diseases of the immune system or serious organ diseases; 5.No history of drug allergies; 6.No treatment with hormonal drugs or radiotherapy in the six months prior to enrolment;

Exclusion criteria

Exclusion criteria: 1.Cervical cancer, pelvic inflammatory disease, vulvar inflammatory disease and acromegaly visible to the naked eye; 2.Women during pregnancy, breastfeeding; 3.The patient has other organic pathologies; 4.Patients who are unable to perform the test according to the study methodology or who do not comply with medical advice;

Design outcomes

Primary

MeasureTime frame
Human papillomavirus (HPV) genotyping of cervical exfoliated cells;

Secondary

MeasureTime frame
Specificity;Sensitivity;Accuracy;Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactXubowen

Shanghai East Hospital

Terry918@sina.com+86 21 3880 4518

Outcome results

None listed

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