Spots Global Cancer Trial Database for Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Official Title: Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Study ID: NCT04650711

Conditions

Cervical Cancer Screening

p16 Protein

Cytology

High-risk Human Papillomavirus

Diagnostic Accuracy

Histology

Cervical Intraepithelial Neoplasia

Interventions

p16 protein expression

Study Description

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.

Detailed Description: