Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia

Summary

Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human papillomavirus (HPV) infection. These abnormalities have been historically detected by cervical cytology, but recent evidence shows that HPV testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. Despite evidence, conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is recommended as a triage test for women with atypical squamous cells of undetermined significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. However, there is no consensus of how to deal women with ASC-US and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the HPV testing in a real-life setting.

Conditions

• Cervical Abnormalities
• Cervical Intraepithelial Neoplasia Grade 2/3
• Cervical Cancer

Interventions

DEVICE

HPV test

QIAGEN - The Digene HPV test®

PROCEDURE

COLPOSCOPY

Colposcopy routine health services

DEVICE

cytology

Cytology routine health services

Sponsors & Collaborators

• International Agency for Research on Cancer

  collaborator OTHER

• Barts and the London School of Medicine and Dentistry

  collaborator OTHER

• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

  collaborator OTHER_GOV

• QIAGEN Gaithersburg, Inc

  collaborator INDUSTRY

• EPS SURA

  collaborator UNKNOWN

• EPS COMFAMA

  collaborator UNKNOWN

• EPS COMFENALCO

  collaborator UNKNOWN

• DINAMICA IPS

  collaborator UNKNOWN

• Laboratorio Clínico Escuela de Microbiología (Universidad de Antioquia)

  collaborator UNKNOWN

• Metrosalud

  collaborator UNKNOWN

• Universidad de Antioquia

  lead OTHER

Principal Investigators

• Gloria I Sanchez, MSc, PhD · Universidad de Antioquia

• Armando Baena, MSc, PhD · Universidad de Antioquia

• Maria C Agudelo, MD · Universidad de Antioquia

• Alejandra Botero, MSc · Universidad de Antioquia

• Victor Florez, MSc · Universidad de Antioquia

• Calatina Villa, BSc · Universidad de Antioquia

• Astrid Bedoya, MSc · Universidad de Antioquia

• Guadalupe Posada, MD, Esp · DINAMICA IPS

• Carlos A Buitrago, MD, Esp · EPS COMFENALCO

• Juan C Ochoa, MD, Esp · EPS COMFAMA

• Luis J Gomez, MD, Esp · DINAMICA IPS

• Tatiana Ramirez, BSc · Universidad de Antioquia

• Maribel Almonte, MSc, PhD · International Agency for Research on Cancer (IARC)

• Rolando Herrero, MSc, PhD · International Agency for Research on Cancer (IARC)

• Peter Sasieni, MSc, PhD · Centre for Cancer Prevention, Queen Mary University of London

• Yessid Álvarez, Student · Universidad de Antioquia

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

69 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Colombia

Study Locations