Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04650711
Study type	Interventional
Source	Peking Union Medical College Hospital
Contact	Lei Li, M.D.
Phone	+8613911988831
Email	lileigh@163.com
Status	Recruiting
Phase	Phase 2
Start date	November 26, 2020
Completion date	November 26, 2020

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