Clinical trial NCT02067468: Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia
Official title: Evaluation of Strategies for Optimal Clinical Management of Women With Atypical Squamous Cells of Undetermined Significance (ASC-US)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Abnormalities
Cervical Intraepithelial Neoplasia Grade 2/3
Cervical Cancer
Keywords: Human Papillomavirus
cervical cancer
health services research
Colombia
Cervical Intraepithelial Neoplasia
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: International Agency for Research on Cancer
name: Barts and the London School of Medicine and Dentistry
name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
name: QIAGEN Gaithersburg, Inc
name: EPS SURA
name: EPS COMFAMA
name: EPS COMFENALCO
name: DINAMICA IPS
name: Laboratorio Clínico Escuela de Microbiología (Universidad de Antioquia)
name: Metrosalud
First posted: 2014-02-20
Enrollment: 2661
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previous abnormal cytology

Primary outcomes:
measure: Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+"
timeFrame: Two years since the enrolment to the exit visit (inclusive)
Secondary outcomes:
measure: Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Reviewed CIN2+"
timeFrame: Two years since the enrolment to the exit visit (inclusive)
measure: 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+"
timeFrame: Exit visit (two years after the enrolment)
measure: Number of Clinical Records (Cytologies, Colposcopies, and Histologies): "Health Care Utilization"
timeFrame: Two years since the enrolment to before the exit visit (i.e., excluding clinical records collected at the exit visit)
measure: Self-esteem
timeFrame: Two years between the enrolment and the exit visit
measure: Trait Anxiety
timeFrame: Two years between the enrolment and the exit visit
measure: State Anxiety
timeFrame: Two years between the enrolment and the exit visit
measure: Concerns About Fertility, Cancer, and Gynecological Health
timeFrame: Two years between the enrolment and the exit visit
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Gloria I Sanchez, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Antioquia
name: Armando Baena, MSc, PhD
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Maria C Agudelo, MD
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Alejandra Botero, MSc
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Victor Florez, MSc
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Calatina Villa, BSc
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Astrid Bedoya, MSc
role: STUDY_CHAIR
affiliation: DINAMICA IPS
name: Guadalupe Posada, MD, Esp
role: STUDY_CHAIR
affiliation: EPS COMFENALCO
name: Carlos A Buitrago, MD, Esp
role: STUDY_CHAIR
affiliation: EPS COMFAMA
name: Juan C Ochoa, MD, Esp
role: STUDY_CHAIR
affiliation: DINAMICA IPS
name: Luis J Gomez, MD, Esp
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Tatiana Ramirez, BSc
role: STUDY_CHAIR
affiliation: International Agency for Research on Cancer (IARC)
name: Maribel Almonte, MSc, PhD
role: STUDY_CHAIR
affiliation: International Agency for Research on Cancer (IARC)
name: Rolando Herrero, MSc, PhD
role: STUDY_CHAIR
affiliation: Centre for Cancer Prevention, Queen Mary University of London
name: Peter Sasieni, MSc, PhD
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Yessid Álvarez, Student
role: STUDY_CHAIR
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