Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol

作者：Maribel Almonte, Raúl Murillo, Gloria Inés Sánchez, Paula González, Annabelle Ferrera, Marı́a Alejandra Picconi, Carolina Wiesner, Aurelio Cruz-Valdéz, Eduardo Lazcano‐Ponce, José Jerónimo, Catterina Ferreccio, Elena Kasamatsu, Laura Mendoza, Guillermo Rodríguez‐Domínguez, Alejandro Calderón, Gino Venegas, Verónica Villagra, Sílvio Tatti, Laura Fleider, Carolina Terán, Armando Baena, María de la Luz Hernández, Mary Luz Rol, Eric Lucas, Sylvaine Barbier, Arianis Tatiana Ramírez, Silvina Arrossi, María Isabel Rodríguez-Riveros, Emmanuel González, Marcela Celis, Sandra Martínez, Yuly Salgado, Marina Ortega, Andrea Verónica Beracochea, Natalia Pérez, Margarita Rodríguez de la Peña, María Antonia Ramón, Pilar Hernández-Nevarez, Margarita Arboleda, Yessy Cabrera, Brenda Salgado, Laura García, Marco Antonio Retana, María Celeste Colucci, Javier Arias‐Stella, Yenny Bellido‐Fuentes, María Liz Bobadilla, Gladys Olmedo, Ivone Brito-García, Armando Méndez-Herrera, Lucía Cardinal, Betsy Flores, Jhacquelin Peñaranda, Josefina Martínez-Better, Ana Soilán, Jacqueline Figueroa, Benedicta Caserta, Carlos R. Sosa, Adrián García-Moreno, Juan Mural, Franco D. Doimi, Diana Giménez, Hernando Rodríguez, Oscar Lora, Silvana Luciani, Nathalie Broutet, Teresa M. Darragh, Rolando Herrero · 发表于：BMJ Open · 年份：2020 · DOI：10.1136/bmjopen-2019-035796 · 被引用次数：44 · 研究领域：Cervical Cancer and HPV Research、Global Cancer Incidence and Screening、Women's cancer prevention and management

INTRODUCTION: Human papillomavirus (HPV) testing is replacing cytology in primary screening. Its limited specificity demands using a second (triage) test to better identify women at high-risk of cervical disease. Cytology represents the immediate triage but its low sensitivity might hamper HPV testing sensitivity, particularly in low-income and middle-income countries (LMICs), where cytology performance has been suboptimal. The ESTAMPA (EStudio multicéntrico de TAMizaje y triaje de cáncer de cuello uterino con pruebas del virus del PApiloma humano; Spanish acronym) study will: (1) evaluate the performance of different triage techniques to detect cervical precancer and (2) inform on how to implement HPV-based screening programmes in LMIC. METHODS AND ANALYSIS: Women aged 30-64 years are screened with HPV testing and Pap across 12 study centres in Latin America. Screened positives have colposcopy with biopsy and treatment of lesions. Women with no evident disease are recalled 18 months later for another HPV test; those HPV-positive undergo colposcopy with biopsy and treatment as needed. Biological specimens are collected in different visits for triage testing, which is not used for clinical management. The study outcome is histological high-grade squamous intraepithelial or worse lesions (HSIL+) under the lower anogenital squamous terminology. About 50 000 women will be screened and 500 HSIL+ cases detected (at initial and 18 months screening). Performance measures (sensitivity...