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NCT04650711 Clinical Trial

Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Cervical Intraepithelial Neoplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04650711
Other study ID # CC-P16
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 26, 2020
Est. completion date November 26, 2020

Study information
Verified date November 2020
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone +8613911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Interventional

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date November 26, 2020
Est. primary completion date November 26, 2020
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• p16 protein expression
P16INK4A immunohistochemical staining is to be performed in residual cytology samples.

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of p16 protein expression Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+) Two years
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