Cervical Cancer Screening, Cervical Intraepithelial Neoplasia, Cytology, Diagnostic Accuracy, High-risk Human Papillomavirus, Histology, p16 Protein
Conditions
Brief summary
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Interventions
DIAGNOSTIC_TESTp16 protein expression
P16INK4A immunohistochemical staining is to be performed in residual cytology samples.
Sponsors
Lei Li
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All eligible participants as a cohort, accept P16INK4A testing, with cytology and/or hrHPV assay
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Signed an approved informed consents * With sufficient cytology sample for p16 testing * With definite results of cytology and/or high-risk human papillomavirus and cervical histology
Exclusion criteria
* Not meeting all of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of p16 protein expression | Two years | Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+) |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Backup ContactMing Wu, M.D.
Outcome results
None listed