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Clinical Value Assessment of New Technologies for Cervical Cancer Screening: P16/Ki-67 Dual-stained Cytology and PAX1 Methylation

Clinical Value Assessment of New Technologies for Cervical Cancer Screening: P16/Ki-67 Dual-stained Cytology and PAX1 Methylation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029231
Enrollment
Unknown
Registered
2020-01-19
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-20

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

Conditions

cervical cancer

Interventions

detection
Gold Standard:Cervical pathology was diagnosed under colposcopy.
p16&#32
Ki-67&#32
double&#32
and&#32
Pax1&#32

Sponsors

The Second People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1)Female aged 18-60; 2)Cervical cytology screening and DNA detection of type 23 high-risk HPV were conducted in the gynecology department of our hospital; 3) No history of uterine and cervical surgery (such as hysterectomy), the whole process of colposcopy can be completed; 4) Cervical biopsy was performed under the colposcopy of our hospital due to abnormal cervical cytology screening, high-risk HPV DNA positive or other reasons.

Exclusion criteria

Exclusion criteria: 1)Patients with precancerous lesions and a history of cervical cancer treatment; 2)Patients with other malignancies other than cervical cancer; 3)Women during pregnancy and within 42 days of giving birth.

Design outcomes

Primary

MeasureTime frame
specificity;Sensitivity;positive predictive value;negative predictive value;Kappa coefficient;Area Under The Curve;

Countries

China

Contacts

Public ContactYu Zhiying

The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital

lizheyzy@163.com+86 13923801588

Outcome results

None listed

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