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

Maribel Almonte; Raúl Murillo; Gloria Inés Sánchez; Paula González; Annabelle Ferrera; María Alejandra Picconi; Carolina Wiesner; Aurelio Cruz-Valdez; Eduardo Lazcano-Ponce; Jose Jerónimo; Catterina Ferreccio; Elena Kasamatsu; Laura Mendoza; Guillermo Rodríguez; Alejandro Calderón; Gino Venegas; Verónica Villagra; Silvio 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; Emmanuel González; Marcela Celis; Sandra Martínez; Yuly Salgado; Marina Ortega; Andrea Verónica Beracochea; Natalia Pérez; Margarita Rodríguez De La Peña; María Ramón; Pilar Hernández-Nevarez; Margarita Arboleda-Naranjo; 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 Sosa; Adrián Moreno; Juan Mural; Franco Doimi; DIana Giménez; Hernando Rodríguez; Oscar Lora; Silvana Luciani; Nathalie Broutet; Teresa Darragh; Rolando Herrero

doi:10.1136/bmjopen-2019-035796

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

Maribel Almonte
, Raúl Murillo
, Gloria Inés Sánchez
, Paula González
, Annabelle Ferrera
, María Alejandra Picconi
, Carolina Wiesner
, Aurelio Cruz-Valdez
, Eduardo Lazcano-Ponce
, Jose Jerónimo
, Catterina Ferreccio
, Elena Kasamatsu
, Laura Mendoza
, Guillermo Rodríguez
, Alejandro Calderón
, Gino Venegas
, Verónica Villagra
, Silvio 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, Emmanuel González, Marcela Celis, Sandra Martínez, Yuly Salgado, Marina Ortega, Andrea Verónica Beracochea, Natalia Pérez, Margarita Rodríguez De La Peña, María Ramón, Pilar Hernández-Nevarez, Margarita Arboleda-Naranjo, 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 Sosa, Adrián Moreno, Juan Mural, Franco Doimi, DIana Giménez, Hernando Rodríguez, Oscar Lora, Silvana Luciani, Nathalie Broutet, Teresa Darragh, Rolando Herrero

International Agency for Research on Cancer
Universidad de Antioquia
Fundación INCIENSA
National Autonomous University of Honduras
Administración Nacional de Laboratorios e Institutos de Salud "Dr. Carlos G. Malbrán"
Instituto Nacional de Cancerología - Colombia
Instituto Nacional de Salud Publica
Liga Contra El Cáncer-Perú
Pontificia Universidad Católica de Chile
Universidad Nacional de Asunción
Comisión Honoraria de Lucha contra el Cáncer
Caja Costarricense de Seguro Social
Clínica Anglo Americana
Universidad de Piura
Laboratorio Central de Salud Pública
Universidad de Buenos Aires
Universidad Mayor
SMS-Oncology
Centro de Estudios de Estado y Sociedad
CCSS
Hospital Nacional, Panama
Ministerio de Salud Pública y Bienestar Social
ASSE
Hospital Policial
Universidad de la República
Hospital Nacional Profesor Dr. Alejandro Posadas
Patología Oncológica SAC
Universidad CES
Secretaría de Salud
Centro Hospitalario Pereira Rossell
Instituto de Patología y Biología Molecular Arias Stella
ESE Hospital Antonio Roldán Betancur
Programa Nacional contra el Cáncer
Hospital Monseñor Victor Manuel Sanabria Martínez
Hospital Gineco-Obstétrico y Neonatal “Dr Jaime Sánchez Porcel”
Pan American Health Organization
World Health Organization
University of California at San Francisco

Research output: Contribution to journal › Article › peer-review

34 Scopus citations

Abstract

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.

Original language	English
Article number	e035796
Journal	BMJ Open
Volume	10
Issue number	5
DOIs	https://doi.org/10.1136/bmjopen-2019-035796
State	Published - 24 May 2020

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

colposcopy
gynaecological oncology
molecular diagnostics
preventive medicine
public health
risk management

Access to Document

10.1136/bmjopen-2019-035796

Cite this

Almonte, M., Murillo, R., Sánchez, G. I., González, P., Ferrera, A., Picconi, M. A., Wiesner, C., Cruz-Valdez, A., Lazcano-Ponce, E., Jerónimo, J., Ferreccio, C., Kasamatsu, E., Mendoza, L., Rodríguez, G., Calderón, A., Venegas, G., Villagra, V., Tatti, S., Fleider, L., ... Herrero, R. (2020). Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: The ESTAMPA screening study protocol. BMJ Open, 10(5), Article e035796. https://doi.org/10.1136/bmjopen-2019-035796

@article{40f3eb2179ce4a1fad31c56997c0548b,

title = "Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: The ESTAMPA screening study protocol",

abstract = "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 multic{\'e}ntrico de TAMizaje y triaje de c{\'a}ncer 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.",

keywords = "colposcopy, gynaecological oncology, molecular diagnostics, preventive medicine, public health, risk management",

author = "Maribel Almonte and Ra{\'u}l Murillo and S{\'a}nchez, \{Gloria In{\'e}s\} and Paula Gonz{\'a}lez and Annabelle Ferrera and Picconi, \{Mar{\'i}a Alejandra\} and Carolina Wiesner and Aurelio Cruz-Valdez and Eduardo Lazcano-Ponce and Jose Jer{\'o}nimo and Catterina Ferreccio and Elena Kasamatsu and Laura Mendoza and Guillermo Rodr{\'i}guez and Alejandro Calder{\'o}n and Gino Venegas and Ver{\'o}nica Villagra and Silvio Tatti and Laura Fleider and Carolina Ter{\'a}n and Armando Baena and Hern{\'a}ndez, \{Mar{\'i}a De La Luz\} and Rol, \{Mary Luz\} and Eric Lucas and Sylvaine Barbier and Ram{\'i}rez, \{Arianis Tatiana\} and Silvina Arrossi and Rodr{\'i}guez, \{Mar{\'i}a Isabel\} and Emmanuel Gonz{\'a}lez and Marcela Celis and Sandra Mart{\'i}nez and Yuly Salgado and Marina Ortega and Beracochea, \{Andrea Ver{\'o}nica\} and Natalia P{\'e}rez and \{Rodr{\'i}guez De La Pe{\~n}a\}, Margarita and Mar{\'i}a Ram{\'o}n and Pilar Hern{\'a}ndez-Nevarez and Margarita Arboleda-Naranjo and Yessy Cabrera and Brenda Salgado and Laura Garc{\'i}a and Retana, \{Marco Antonio\} and Colucci, \{Mar{\'i}a Celeste\} and Javier Arias-Stella and Yenny Bellido-Fuentes and Bobadilla, \{Mar{\'i}a Liz\} and Gladys Olmedo and Ivone Brito-Garc{\'i}a and Armando M{\'e}ndez-Herrera and Luc{\'i}a Cardinal and Betsy Flores and Jhacquelin Pe{\~n}aranda and Josefina Mart{\'i}nez-Better and Ana Soil{\'a}n and Jacqueline Figueroa and Benedicta Caserta and Carlos Sosa and Adri{\'a}n Moreno and Juan Mural and Franco Doimi and DIana Gim{\'e}nez and Hernando Rodr{\'i}guez and Oscar Lora and Silvana Luciani and Nathalie Broutet and Teresa Darragh and Rolando Herrero",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.",

year = "2020",

month = may,

day = "24",

doi = "10.1136/bmjopen-2019-035796",

language = "English",

volume = "10",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "5",

}

Almonte, M, Murillo, R, Sánchez, GI, González, P, Ferrera, A, Picconi, MA, Wiesner, C, Cruz-Valdez, A, Lazcano-Ponce, E, Jerónimo, J, Ferreccio, C, Kasamatsu, E, Mendoza, L, Rodríguez, G, Calderón, A, Venegas, G, Villagra, V, Tatti, S, Fleider, L, Terán, C, Baena, A, Hernández, MDLL, Rol, ML, Lucas, E, Barbier, S, Ramírez, AT, Arrossi, S, Rodríguez, MI, González, E, Celis, M, Martínez, S, Salgado, Y, Ortega, M, Beracochea, AV, Pérez, N, Rodríguez De La Peña, M, Ramón, M, Hernández-Nevarez, P, Arboleda-Naranjo, M, Cabrera, Y, Salgado, B, García, L, Retana, MA, Colucci, MC, Arias-Stella, J, Bellido-Fuentes, Y, Bobadilla, ML, Olmedo, G, Brito-García, I, Méndez-Herrera, A, Cardinal, L, Flores, B, Peñaranda, J, Martínez-Better, J, Soilán, A, Figueroa, J, Caserta, B, Sosa, C, Moreno, A, Mural, J, Doimi, F, Giménez, DI, Rodríguez, H, Lora, O, Luciani, S, Broutet, N, Darragh, T & Herrero, R 2020, 'Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: The ESTAMPA screening study protocol', BMJ Open, vol. 10, no. 5, e035796. https://doi.org/10.1136/bmjopen-2019-035796

TY - JOUR

T1 - Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America

T2 - The ESTAMPA screening study protocol

AU - Almonte, Maribel

AU - Murillo, Raúl

AU - Sánchez, Gloria Inés

AU - González, Paula

AU - Ferrera, Annabelle

AU - Picconi, María Alejandra

AU - Wiesner, Carolina

AU - Cruz-Valdez, Aurelio

AU - Lazcano-Ponce, Eduardo

AU - Jerónimo, Jose

AU - Ferreccio, Catterina

AU - Kasamatsu, Elena

AU - Mendoza, Laura

AU - Rodríguez, Guillermo

AU - Calderón, Alejandro

AU - Venegas, Gino

AU - Villagra, Verónica

AU - Tatti, Silvio

AU - Fleider, Laura

AU - Terán, Carolina

AU - Baena, Armando

AU - Hernández, María De La Luz

AU - Rol, Mary Luz

AU - Lucas, Eric

AU - Barbier, Sylvaine

AU - Ramírez, Arianis Tatiana

AU - Arrossi, Silvina

AU - Rodríguez, María Isabel

AU - González, Emmanuel

AU - Celis, Marcela

AU - Martínez, Sandra

AU - Salgado, Yuly

AU - Ortega, Marina

AU - Beracochea, Andrea Verónica

AU - Pérez, Natalia

AU - Rodríguez De La Peña, Margarita

AU - Ramón, María

AU - Hernández-Nevarez, Pilar

AU - Arboleda-Naranjo, Margarita

AU - Cabrera, Yessy

AU - Salgado, Brenda

AU - García, Laura

AU - Retana, Marco Antonio

AU - Colucci, María Celeste

AU - Arias-Stella, Javier

AU - Bellido-Fuentes, Yenny

AU - Bobadilla, María Liz

AU - Olmedo, Gladys

AU - Brito-García, Ivone

AU - Méndez-Herrera, Armando

AU - Cardinal, Lucía

AU - Flores, Betsy

AU - Peñaranda, Jhacquelin

AU - Martínez-Better, Josefina

AU - Soilán, Ana

AU - Figueroa, Jacqueline

AU - Caserta, Benedicta

AU - Sosa, Carlos

AU - Moreno, Adrián

AU - Mural, Juan

AU - Doimi, Franco

AU - Giménez, DIana

AU - Rodríguez, Hernando

AU - Lora, Oscar

AU - Luciani, Silvana

AU - Broutet, Nathalie

AU - Darragh, Teresa

AU - Herrero, Rolando

PY - 2020/5/24

Y1 - 2020/5/24

N2 - 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.

AB - 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.

KW - colposcopy

KW - gynaecological oncology

KW - molecular diagnostics

KW - preventive medicine

KW - public health

KW - risk management

UR - https://www.scopus.com/pages/publications/85085413753

U2 - 10.1136/bmjopen-2019-035796

DO - 10.1136/bmjopen-2019-035796

M3 - Article

C2 - 32448795

AN - SCOPUS:85085413753

SN - 2044-6055

VL - 10

JO - BMJ Open

JF - BMJ Open

IS - 5

M1 - e035796

ER -

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

Abstract

UN SDGs

Keywords

Access to Document

Other files and links

Fingerprint

Cite this