Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol
Authors: Almonte Maribel , Murillo Raúl , Sánchez Gloria Inés , González Paula , Ferrera Annabelle , Picconi María Alejandra , Wiesner Carolina , Cruz-Valdez Aurelio , Lazcano-Ponce Eduardo , Jerónimo Jose , Ferreccio Catterina , Kasamatsu Elena , Mendoza Laura , Rodríguez Guillermo , Calderón Alejandro , Venegas Gino , Villagra Verónica , Tatti Silvio , Fleider Laura , Terán Carolina , Baena Armando , Hernández María de la Luz , Rol Mary Luz , Lucas Eric , Barbier Sylvaine , Ramírez Arianis Tatiana , Arrossi Silvina , Rodríguez María Isabel , González Emmanuel , Celis Marcela , Martínez Sandra , Salgado Yuly , Ortega Marina , Beracochea Andrea Verónica , Pérez Natalia , Rodríguez de la Peña Margarita , Ramón María , Hernández-Nevarez Pilar , Arboleda-Naranjo Margarita , Cabrera Yessy , Salgado Brenda , García Laura , Retana Marco Antonio , Colucci María Celeste , Arias-Stella Javier , Bellido-Fuentes Yenny , Bobadilla María Liz , Olmedo Gladys , Brito-García Ivone , Méndez-Herrera Armando , Cardinal Lucía , Flores Betsy , Peñaranda Jhacquelin , Martínez-Better Josefina , Soilán Ana , Figueroa Jacqueline , Caserta Benedicta , Sosa Carlos , Moreno Adrián , Mural Juan , Doimi Franco , Giménez Diana , Rodríguez Hernando , Lora Oscar , Luciani Silvana , Broutet Nathalie , Darragh Teresa , Herrero Rolando 
Published: May 2020

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, specificity and predictive values) of triage techniques to detect HSIL+ will be estimated and compared with adjustment by age and study centre.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of the International Agency for Research on Cancer (IARC), of the Pan American Health Organisation (PAHO) and by those in each participating centre. A Data and Safety Monitoring Board (DSMB) has been established to monitor progress of the study, assure participant safety, advice on scientific conduct and analysis and suggest protocol improvements. Study findings will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number

NCT01881659