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

NCT ID: NCT02067468

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2661 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-04-30

Brief 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.

Detailed Description

The aim of this study is to compare the effectiveness and efficiency of immediate colposcopy (IC), repeat conventional cytology at 6 and 12 months (RC) and HPV triage (HPV) (QIAGEN-The digene HPV Test®) for the clinical management of women with ASC-US insured in healthcare management organizations (HMO) within the Colombian health security system. This study randomized 2,661 20-69 years old women with ASC-US, insured in HMOs in Medellin-Colombia to 3 arms: IC, RC and HPV. All women are scheduled for a visit at 2 years after recruitment that includes HPV-test/cytology and colposcopy either if HPV+ (RLU>=1) or abnormal cytology (>=ASC-US). This colposcopy is performed by a trained colposcopist and women are followed-up according to a well-defined algorithm. The fewer high-grade cervical neoplasia (CIN2+) rate at the end of following will determine the most effective arm. The most efficiency arm will be which reach the major effective with the minimum resource (cytologies, colposcopies and histologies) consumed. The resource consumed is being retrieved from the HMOs. This study also pretends to evaluate the acceptability of the HPV testing. This study will allow us to know if within the Colombian health security system, the HPV test will remain superior to repeating cytology and/or to immediate colposcopy as it has been demonstrated in randomized controlled trials carried out in outside settings.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

HPV test

Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy

Group Type: EXPERIMENTAL

HPV test

Intervention Type: DEVICE

QIAGEN - The Digene HPV test®

COLPOSCOPY

Intervention Type: PROCEDURE

Colposcopy routine health services

COLPOSCOPY

Women with ASC-US cytology are immediately refer to colposcopy

Group Type: ACTIVE_COMPARATOR

COLPOSCOPY

Intervention Type: PROCEDURE

Colposcopy routine health services

CYTOLOGY

Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher

Group Type: ACTIVE_COMPARATOR

COLPOSCOPY

Intervention Type: PROCEDURE

Colposcopy routine health services

cytology

Intervention Type: DEVICE

Cytology routine health services

Interventions

HPV test

QIAGEN - The Digene HPV test®

Intervention Type: DEVICE

COLPOSCOPY

Colposcopy routine health services

Intervention Type: PROCEDURE

cytology

Cytology routine health services

Intervention Type: DEVICE

Other Intervention Names

Human Papillomavirus test; DNA HPV test; High risk HPV test; Pap smear; Papanicolaou test; cervical cytology

Eligibility Criteria

Inclusion Criteria

• ASC-US cytology, living in metropolitan area of Medellin

Exclusion Criteria

• Previous abnormal cytology

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

International Agency for Research on Cancer

OTHER

Sponsor Role: collaborator

Barts and the London School of Medicine and Dentistry

OTHER

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: collaborator

QIAGEN Gaithersburg, Inc

INDUSTRY

Sponsor Role: collaborator

EPS SURA

UNKNOWN

Sponsor Role: collaborator

EPS COMFAMA

UNKNOWN

Sponsor Role: collaborator

EPS COMFENALCO

UNKNOWN

Sponsor Role: collaborator

DINAMICA IPS

UNKNOWN

Sponsor Role: collaborator

Laboratorio Clínico Escuela de Microbiología (Universidad de Antioquia)

UNKNOWN

Sponsor Role: collaborator

Metrosalud

UNKNOWN

Sponsor Role: collaborator

Universidad de Antioquia

OTHER

Sponsor Role: lead

Responsible Party

Gloria I. Sanchez, MSc, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gloria I Sanchez, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Armando Baena, MSc, PhD

Role: STUDY_CHAIR

Universidad de Antioquia

Maria C Agudelo, MD

Role: STUDY_CHAIR

Universidad de Antioquia

Alejandra Botero, MSc

Role: STUDY_CHAIR

Universidad de Antioquia

Victor Florez, MSc

Role: STUDY_CHAIR

Universidad de Antioquia

Calatina Villa, BSc

Role: STUDY_CHAIR

Universidad de Antioquia

Astrid Bedoya, MSc

Role: STUDY_CHAIR

Universidad de Antioquia

Guadalupe Posada, MD, Esp

Role: STUDY_CHAIR

DINAMICA IPS

Carlos A Buitrago, MD, Esp

Role: STUDY_CHAIR

EPS COMFENALCO

Juan C Ochoa, MD, Esp

Role: STUDY_CHAIR

EPS COMFAMA

Luis J Gomez, MD, Esp

Role: STUDY_CHAIR

DINAMICA IPS

Tatiana Ramirez, BSc

Role: STUDY_CHAIR

Universidad de Antioquia

Maribel Almonte, MSc, PhD

Role: STUDY_CHAIR

International Agency for Research on Cancer (IARC)

Rolando Herrero, MSc, PhD

Role: STUDY_CHAIR

International Agency for Research on Cancer (IARC)

Peter Sasieni, MSc, PhD

Role: STUDY_CHAIR

Centre for Cancer Prevention, Queen Mary University of London

Yessid Álvarez, Student

Role: STUDY_CHAIR

Universidad de Antioquia

Locations

Universidad de Antioquia

Medellín, Antioquia, Colombia

Countries

Colombia

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Other Identifiers

111545921657

Identifier Type: -

Identifier Source: org_study_id