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Comparison of immediate colposcopy, repeat conventional cytology and high-risk human papillomavirus testing for the clinical management of atypical squamous cells of undetermined significance cytology in routine health services of Medellin, Colombia: The ASCUS-COL trial

Research output: Contribution to journalArticlepeer-review

for the ASCUS-COL Trial Group

Original languageEnglish
Pages (from-to)1394-1407
Number of pages14
JournalInternational Journal of Cancer
Volume148
Issue number6
DOIs
Published15 Mar 2021

Bibliographical note

Funding Information: ASCUS-COL Trial Group: Gloria I Sanchez (PI), Armando Baena, Maria C Agudelo, Arianis Tatiana Ramirez, Kelly Melisa Casta?eda, Mauricio Borrero, Marcela Riveros, Astrid Bedoya, Alejandra Botero, Catalina Villa and Victor Florez (Group Infection and Cancer, UdeA), Carolina Lopez (Department of Pathology, School of Medicine, UdeA), Maribel Almonte (Prevention and Implementation Group, International Agency for Research on Cancer. Lyon, France), Rolando Herrero (Agencia Costarricense de Investigaciones Biom?dicas, Guanacaste, Costa Rica), Mark Stoler (Department of Pathology and Laboratory Medicine, University of Virginia, Charlottesville, VA, USA), Philip E Castle (Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA), Peter Sasieni (Faculty of Life Sciences & Medicine, School of Cancer & Pharmaceutical Sciences, Guys Cancer Centre, Guys Hospital, King's College London, London, UK), Guadalupe Posada (Department of Gynecology, Dinamica IPS, Medellin, Colombia), Luis Jaime Gomez, (Dinamica IPS), Carlos A Buitrago (Department of Gynecology and Obstetrics, Clinica SOMA), Juan C Ochoa (Unidad de Video diagnostica de la Mujer), David Suescun, (Laboratory of Pathology and Cytology Suescun). Members of the ASCUS-COL Trial Group responsible for the collection of data included in the trial are also acknowledged: Claudia Cristina Rivera, Liliana Gamboa, Maria Elena Londo?o, Natalia Echeverry, Ruth Elena Arboleda, Sandra Herrera (Group Infection and Cancer), Maria Eugenia Mejia and Marleny Valencia (School of Microbiology, Universidad de Antioquia, Medellin, Colombia), Lina Toro and Jhon Henry Osorio (Comfama EPS, Medellin, Colombia), Jaime Agudelo, Gustavo Trujillo, Cristina Jimenez and Lizeth Ruiz (Comfenalco EPS, Medellin, Colombia), Mary Luz Arteaga and Liliana Rendon (Savia Salud EPS, Medellin, Colombia), Lina Serna and Jose Miguel Abad (Sura EPS, Medellin, Colombia), Beatriz Eugenia Perez, Gloria Cristina Calderon and Jaime Alexander Casta?eda (Dinamica IPS, Medellin, Colombia), Luz Helena Londo?o (Metrosalud IPS, Medellin, Colombia), Lucy Sanchez (Biosigno IPS and CEMEV IPS, Medellin, Colombia). We are grateful to women who participated in the study. Colciencias (Grant 1115-459-21657), Fundaci?n Pedro Nel Cardona, Estrategia de Sostenibilidad 2013-2014 Universidad de Antioquia (Grant CPT-1208). Armando Baena, Maria C. Agudelo and Arianis Tatiana Ram?rez were recipients of doctoral fellowships from Colciencias. Funding from Colciencias and British Council for the international exchange of investigators and innovators between Colombia and UK (call 614, 2013) are also acknowledged. Funders had no role in study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author (P.I. of the study) had full access to all the data in the study and had final responsibility for the decision to submit for publication. Publisher Copyright: © 2020 Union for International Cancer Control Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

In the context of opportunistic cervical cancer screening settings of low-and-middle-income countries, little is known about the benefits of high-risk human papillomavirus (hrHPV) testing on high-grade cervical abnormality detection among women with atypical squamous cells of undetermined significance (ASC-US) cytology in routine clinical practice. We compared the effectiveness of immediate colposcopy (IC), conventional cytology at 6 and 12 months (colposcopy if ≥ASC-US) (RC) and hrHPV testing (colposcopy if hrHPV-positive) (HPV) to detect cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+) among women aged 20 to 69 years with ASC-US in routine care. Participants (n = 2661) were evenly randomized into three arms (n = 882 IC, n = 890 RC, n = 889 HPV) to receive services by routine healthcare providers and invited to an exit visit 24 months after recruitment. Histopathology was blindly reviewed by a quality-control external panel (QC). The primary endpoint was the first QC-diagnosed CIN2+ or CIN3+ detected during three periods: enrolment (≤6 months for IC and HPV, ≤12 months for RC), follow-up (between enrolment and exit visit) and exit visit. The trial is completed. Colposcopy was done on 88%, 42% and 52% of participants in IC, RC and HPV. Overall, 212 CIN2+ and 52 CIN3+ cases were diagnosed. No differences were observed for CIN2+ detection (P =.821). However, compared to IC, only HPV significantly reduced CIN3+ cases that providers were unable to detect during the 2-year routine follow-up (relative proportion 0.35, 95% CI 0.09-0.87). In this context, hrHPV testing was the most effective and efficient management strategy for women with ASC-US cytology.

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