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Analysis of sensitivity and specificity of four algorithms for cervical cancer screening combining cervical cytology and Human Papillomavirus molecular test (HPV)

Abstract

The aim of the study is to evaluate four algorithms for cervical cancer screening using a combination of cervical cytology (liquid-based) and molecular test for high-risk HPV. The screening test will be considered positive in case of: 1) Algorithm # 1: any abnormality in cervical cytology; 2) Algorithm # 2: any abnormality in cervical cytology and subsequent positive HPV test; 3) # Algorithm 3: positive HPV test, 4) Algorithm # 4: positive HPV test and subsequent abnormality in cervical cytology. The study will prospectively include 2,000 women aged 25 to 64 years in the Prevention Departament of Barretos Cancer Hospital - Pio XII Foundation. Cervical smears will be collected in a liquid-based device (SurePath ™, Becton & Dickinson). The HPV molecular test will be performed by PCR (Polymerase Chain Reaction) using the Cobas X480™ (Roche). Ali women will undergo colposcopy at the same opportunity of cervical smears, regardless of the cytology result. Those women who present abnormality in the colposcopy will be undergo cervical biopsy of the suspected areas. The accuracy of each algorithm will be measured by sensitivity and specificity. The cervical biopsies (or conization products) will be considered the gold standard test. Women who have satisfactory colposcopy and no biopsy will be classified as "negative disease". The confidence intervals (95%) of the accuracy indicators will be calculated in order to compare the four algorithms. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
ROGERI, CAROLINE DOMINGUES; SANTEJO SILVEIRA, HENRIQUE CESAR; CAUSIN, RHAFAELA LIMA; VILLA, LUISA LINA; STEIN, MAIRA DEGIOVANI; DE CARVALHO, ANA CAROLINA; REBOLHO BATISTA ARANTES, LIDIA MARIA; SCAPULATEMPO-NETO, CRISTOVAM; POSSATI-RESENDE, JULIO CESAR; ANTONIAZZI, MARCIO; LONGATTO-FILHO, ADHEMAR; TAVARES GUERREIRO FREGNANI, JOSE HUMBERTO. Methylation of the hsa-miR-124, SOX1, TERT, and LMX1A genes as biomarkers for precursor lesions in cervical cancer. GYNECOLOGIC ONCOLOGY, v. 150, n. 3, p. 545-551, SEP 2018. Web of Science Citations: 5.
MARIANO, VANIA SAMMARTINO; LORENZI, ADRIANA TARLA; SCAPULATEMPO-NETO, CRISTOVAM; STEIN, MAIRA DEGIOVANI; POSSATI RESENDE, JULIO CESAR; ANTONIAZZI, MARCIO; VILLA, LUISA LINA; LEVI, JOSE EDUARDO; LONGATTO-FILHO, ADHEMAR; TAVARES GUERREIRO FREGNANI, JOSE HUMBERTO. A Low-Cost HPV Immunochromatographic Assay to Detect High-Grade Cervical Intraepithelial Neoplasia. PLoS One, v. 11, n. 10 OCT 20 2016. Web of Science Citations: 3.

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