Brief Title
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
Official Title
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Diagnostic accuracy of p16 protein expression
Condition
Cervical Cancer Screening
Intervention
p16 protein expression
Study Arms / Comparison Groups
Study group
Description: All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
250
Start Date
November 26, 2020
Completion Date
November 26, 2020
Primary Completion Date
November 26, 2020
Eligibility Criteria
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
Gender
Female
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lei Li, M.D., +8613911988831, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04650711
Organization ID
CC-P16
Responsible Party
Sponsor-Investigator
Study Sponsor
Lei Li
Study Sponsor
Lei Li, M.D., Principal Investigator, Peking Union Medical College Hospital
Verification Date
November 2020