"EVALUATION OF THE USE OF THE BIOMARKER p16 IN CERVICAL BIOPSIES IN THE DIAGNOSTIC DEFINITION AND MANAGEMENT OF WOMEN SCREENED WITH POSITIVE HPV TEST".

• Grant number: 24/04037-0
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): July 01, 2024
• Effective date (End): June 30, 2025
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Júlio César Teixeira
• Grantee: Mariana Jundurian
• Host Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil

Abstract

Cervical cancer remains highly relevant in the Brazilian scenario, and to decrease its prevalence, a new screening program with HPV DNA testing replacing cytology has been underway in the city of Indaiatuba (SP) since 2017. This program is supervised and monitored by researchers from Unicamp through a study that maintains a database with all results, continuously updated. Results published after five years indicate high coverage and an increase in the detection of precursor lesions and cancers. From the outset, quality control in the histological diagnosis of cervical biopsies utilized testing for p16 expression. p16 expression indicates a higher risk of precursor lesion progression to cancer, while its absence identifies a lesion with a greater potential for regression, suggesting a conservative approach. p16 expression was conducted in an external laboratory using automated immunohistochemistry and employed by the program's pathologists. As of 2023 (Year 6 of the program), this test is no longer available. The aim of this study is to assess the utility of evaluating p16 expression in biopsies from women screened with HPV DNA testing between 2017 and 2022 for diagnostic confirmation and to assist in clinical decision-making. The original study anticipated the proposed analysis as one of its objectives and was approved by the Ethics Committee. Information will be extracted from the original study's database to construct a spreadsheet with cases involving cervical biopsies and p16 expression evaluation. Cases will be reviewed, and an anonymized spreadsheet will be used for descriptive statistical analysis and calculation of negative and positive predictive values for high-grade precursor lesions according to p16 expression, as well as the modification of case management.