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Evaluation of the diagnostic efficacy of HR-HPV DNA and p16/Ki-67 dual-stain co-testing in cervical cancer opportunistic screening in outpatient population in China

Evaluation of the diagnostic efficacy of HR-HPV DNA and p16/Ki-67 dual-stain co-testing in cervical cancer opportunistic screening in outpatient population in China

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095524
Enrollment
Unknown
Registered
2025-01-08
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

cervical cancer

Interventions

Gold Standard:Colposcopic cervical biopsy results
Index test:p16/ki-67 double stain test, HR-HPV DNA test, LBC test

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Women aged 25-65 years old who attend outpatient clinics and have a sexual life history; 2) Women who meet the cervical cancer opportunistic screening population (including clinicians who recommend such screening and patients who themselves request cervical cancer screening)

Exclusion criteria

Exclusion criteria: 1) Women with no history of sexual life; 2) Pregnant or lactating women; 3) acute inflammation of reproductive tract; 4) Women who had cervical exfoliated cells collected within 2 months prior to this study; 5) Women to be referred for colposcopy or women with negative colposcopy results within one year; 6) Women with immune deficiencies; 7) Women with a previous diagnosis of CIN or cervical cancer; 8) Women with a history of other gynecological malignancies; 9) Women with a history of hysterectomy; 10) Women with a history of pelvic radiation therapy; 11) Women who have previously undergone surgical treatment for cervical lesions (LEEP knife, cold knife coning, etc.) 12) Women who have had vaginal medication or physical therapy within the past 3 months; 13) Women with mental disorders.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;Positive predictive value;Negative predictive value;

Countries

China

Contacts

Public ContactXiang Yang

Peking Union Medical College Hospital

xiangy@pumch.cn+86 135 1105 0222

Outcome results

None listed

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