Trials / Unknown
UnknownNCT04650711
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- Lei Li · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cervical Cancer Screening
- p16 Protein
- Cytology
- High-risk Human Papillomavirus
- Diagnostic Accuracy
- Histology
- Cervical Intraepithelial Neoplasia
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | p16 protein expression | P16INK4A immunohistochemical staining is to be performed in residual cytology samples. |
Timeline
- Start date
- 2020-11-26
- Primary completion
- 2020-11-26
- Completion
- 2020-11-26
- First posted
- 2020-12-03
- Last updated
- 2020-12-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04650711. Inclusion in this directory is not an endorsement.