Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia (ASCUS-COL)

September 18, 2019 updated by: Gloria I. Sanchez, MSc, PhD, Universidad de Antioquia

Evaluation of Strategies for Optimal Clinical Management of Women With Atypical Squamous Cells of Undetermined Significance (ASC-US)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2661

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Universidad de Antioquia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous abnormal cytology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPV test
Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy
Device: HPV test
QIAGEN - The Digene HPV test®
Other Names:
  • Human Papillomavirus test
  • DNA HPV test
  • High risk HPV test
Procedure: COLPOSCOPY
Colposcopy routine health services
Active Comparator: COLPOSCOPY
Women with ASC-US cytology are immediately refer to colposcopy
Procedure: COLPOSCOPY
Colposcopy routine health services
Active Comparator: 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
Procedure: COLPOSCOPY
Colposcopy routine health services
Device: cytology
Cytology routine health services
Other Names:
  • Pap smear
  • Papanicolaou test
  • cervical cytology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"
Time Frame: Two years since the enrolment to the exit visit (inclusive)
Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by the community pathologists during the two years of follow-up. The first community-based CIN2+ diagnosis was adjudicated to the participant (including the exit visit if none community-based CIN2+ during the two years of follow-up). This outcome is used for the effectiveness analysis of the three strategies.
Two years since the enrolment to the exit visit (inclusive)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Reviewed CIN2+"
Time Frame: Two years since the enrolment to the exit visit (inclusive)
Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by a panel of external experts obtained after histological review of biopsies emitted by the community pathologists. Biopsies obtained during the two years of follow-up and the exit visit were reviewed by a panel of two external experts and a final result was adjudicated to each participant based on the panel of experts and the community of pathologists. This outcome is used for the effectiveness analysis of the three strategies.
Two years since the enrolment to the exit visit (inclusive)
Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+) at the Exit Visit, Two Years After the Enrolment: "Exit-reviewed CIN2+"
Time Frame: Exit visit (two years after the enrolment)
Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by a panel of external experts after reviewing biopsies collected at the exit visit, two years after the enrolment. This outcome is an estimate of the remaining disease that was not detected by the strategies during the 2 years of follow-up. The outcome was obtained after the review of all the biopsies taken during the exit visit. Biopsies were taken using a standardized research protocol to ensure the completeness of the remaining disease. Basically, all women attending the exit visit were tested with HPV testing and Pap and referred to colposcopy if any HPV positive or abnormal cytology. The colposcopy was performed by a researcher of the study team who took up to two biopsies from the observed lesion plus one or two at random if none lesion was observed. All biopsies were reviewed by the external panel. This outcome is used for the efficiency analysis of the three strategies.
Exit visit (two years after the enrolment)
Number of Clinical Records (Cytologies, Colposcopies, and Histologies): "Health Care Utilization"
Time Frame: Two years since the enrolment to before the exit visit (i.e., excluding clinical records collected at the exit visit)
The outcome is defined as the number of cytologies, colposcopies, and histologies routinely performed during the two years of follow-up. Records were identified in databases or manually searched from clinical records. This outcome will be used for the analysis of the efficiency of the three strategies.
Two years since the enrolment to before the exit visit (i.e., excluding clinical records collected at the exit visit)
Self-esteem
Time Frame: Two years between the enrolment and the exit visit
Self-esteem corresponds to the self-assessment of a positive or negative evaluation toward oneself. This outcome was measured using the Rosenberg Scale through 10 Likert-type questions with scores varying between 1 and 4 (1=strongly agree, 2=agree, 3=disagree, 4=strongly disagree). Total values range between 10 and 40 where lower scores suggest lower self-esteem. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.
Two years between the enrolment and the exit visit
Trait Anxiety
Time Frame: Two years between the enrolment and the exit visit
Trait anxiety refers to the sustainable tendency to experience negative emotions (such as fears, worries, and anxiety) in various situations. This outcome was measured using the Spielberger State-Trait-Anxiety Inventory (STAI) through 20 Likert-type questions with scores varying between 0 and 3 (0=not at all, 1=somewhat, 2=moderately, 3=very much). Total values range between 0 and 60 where higher scores suggest higher levels of anxiety. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.
Two years between the enrolment and the exit visit
State Anxiety
Time Frame: Two years between the enrolment and the exit visit
State anxiety refers to the transitory tendency to experience negative emotions (such as fears, worries, and anxiety). This outcome was measured using the Spielberger State-Trait-Anxiety Inventory (STAI) through 20 Likert-type questions with scores varying between 0 and 3 (0=not at all, 1=somewhat, 2=moderately, 3=very much). Total values range between 0 and 60 where higher scores suggest higher levels of anxiety. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.
Two years between the enrolment and the exit visit
Concerns About Fertility, Cancer, and Gynecological Health
Time Frame: Two years between the enrolment and the exit visit
This outcome was measured using the HPV Impact Profile (HIP) scale through the following five domains: concerns about cancer and loss of fertility; emotional impact (depression and anxiety); self-image; interaction with the medical staff (pain or discomfort during the visit); and impact upon the life and its control. The response to each domain was measured on a scale from 0 to 10 (0=not at all, 1-3=a little, 4-6=somewhat, 7-9=a great deal, 10=extremely) and was then transformed to a scale from 0 to 100. A total score was calculated by adding all the items. Values <40 indicate no or little impact, between 40 and 70 moderate impact, and >70 indicate high psychosocial impact. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.
Two years between the enrolment and the exit visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Collaborators

Barts and the London School of Medicine and Dentistry
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
International Agency for Research on Cancer
QIAGEN Gaithersburg, Inc
EPS SURA
EPS COMFAMA
EPS COMFENALCO
DINAMICA IPS
Laboratorio Clínico Escuela de Microbiología (Universidad de Antioquia)
Metrosalud

Investigators

  • Principal Investigator: Gloria I Sanchez, MSc, PhD, Universidad de Antioquia
  • Study Chair: Armando Baena, MSc, PhD, Universidad de Antioquia
  • Study Chair: Maria C Agudelo, MD, Universidad de Antioquia
  • Study Chair: Alejandra Botero, MSc, Universidad de Antioquia
  • Study Chair: Victor Florez, MSc, Universidad de Antioquia
  • Study Chair: Calatina Villa, BSc, Universidad de Antioquia
  • Study Chair: Astrid Bedoya, MSc, Universidad de Antioquia
  • Study Chair: Guadalupe Posada, MD, Esp, DINAMICA IPS
  • Study Chair: Carlos A Buitrago, MD, Esp, EPS COMFENALCO
  • Study Chair: Juan C Ochoa, MD, Esp, EPS COMFAMA
  • Study Chair: Luis J Gomez, MD, Esp, DINAMICA IPS
  • Study Chair: Tatiana Ramirez, BSc, Universidad de Antioquia
  • Study Chair: Maribel Almonte, MSc, PhD, International Agency For Research On Cancer (IARC)
  • Study Chair: Rolando Herrero, MSc, PhD, International Agency For Research On Cancer (IARC)
  • Study Chair: Peter Sasieni, MSc, PhD, Centre for Cancer Prevention, Queen Mary University of London
  • Study Chair: Yessid Álvarez, Student, Universidad de Antioquia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111545921657

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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