N/A
N=2,661
Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia
Cervical Abnormalities · Cervical Intraepithelial Neoplasia Grade 2/3 · Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02067468 ↗Enrolled (actual)
2,661
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+" — 847; 835; 848; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HPV test (Device); COLPOSCOPY (Procedure); cytology (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Universidad de Antioquia
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+" |
847; 835; 848; 30; 43; 31 | — |
| SECONDARY Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Reviewed CIN2+" |
813; 809; 827; 51; 61; 48 | — |
| SECONDARY 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+" |
852; 851; 866; 30; 39; 23 | — |
| SECONDARY Number of Clinical Records (Cytologies, Colposcopies, and Histologies): "Health Care Utilization" |
904; 1218; 816; 964; 509; 633 | — |
| SECONDARY Self-esteem |
32.9; 33.0; 32.8; 34.8; 33.9; 34.4 | — |
| SECONDARY Trait Anxiety |
17.5; 17.4; 17.7; 16.3; 16.8; 17.7 | — |
| SECONDARY State Anxiety |
15.3; 13.6; 14.3; 14.1; 13.4; 14.1 | — |
| SECONDARY Concerns About Fertility, Cancer, and Gynecological Health |
35.3; 38.1; 36.0; 25.0; 25.7; 27.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ASC-US cytology, living in metropolitan area of Medellin
Exclusion Criteria
- Previous abnormal cytology
Data sourced from ClinicalTrials.gov (NCT02067468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.