Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Phase 2

• Conditions: p16 Protein; Cytology; High-risk Human Papillomavirus; Histology; Diagnostic Accuracy; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia
• Interventions: Diagnostic Test: p16 protein expression

• Registration Number: NCT04650711
• Lead Sponsor: Lei Li

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

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study Start: 2020-11-26
• Primary Completion: 2020-11-26
• Study Completion: 2020-11-26
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	p16 protein expression	All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay.

Primary Outcome Measures

Name	Time	Method
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+)

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China