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

IntroductionHuman 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...

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Published in:	BMJ open Vol. 10; no. 5; p. e035796
Main 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
Format:	Journal Article
Language:	English
Published:	England BMJ Publishing Group LTD 24-05-2020 BMJ Publishing Group
Series:	Protocol
Subjects:	Adult Alphapapillomavirus - isolation & purification Cellular biology Cervical cancer Cervical Intraepithelial Neoplasia - diagnosis Colposcopy Cost control Early Detection of Cancer Female Human papillomavirus Humans Infections Latin America Medical diagnosis Medical screening Middle Aged Papillomavirus Infections - diagnosis Public Health Triage Uterine Cervical Neoplasms - diagnosis Womens health Latin America colposcopy molecular diagnostics risk management gynaecological oncology public health preventive medicine
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Summary:	IntroductionHuman 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 analysisWomen 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 disseminationThe 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 numberNCT01881659
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2019-035796