Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Lei Li

Status and phase: Unknown; Phase 2

Conditions: Diagnostic Accuracy; Histology; High-risk Human Papillomavirus; Cervical Cancer Screening; p16 Protein; Cytology; Cervical Intraepithelial Neoplasia

Treatments: Diagnostic Test: p16 protein expression

Study type: Interventional

Funder types: Other

Identifiers

NCT04650711

CC-P16

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Study group

Experimental group

Description:

All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay.

Treatment:

Diagnostic Test: p16 protein expression