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

Universidad de Antioquia

Status: Completed

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

Treatments: Device: HPV test; Procedure: COLPOSCOPY; Device: cytology

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02067468

111545921657

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,661 patients

Sex: Female

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previous abnormal cytology

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2,661 participants in 3 patient groups

HPV test

Experimental group

Description:

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

Treatment:

Device: HPV test

Procedure: COLPOSCOPY

COLPOSCOPY

Active Comparator group

Description:

Women with ASC-US cytology are immediately refer to colposcopy

Treatment:

Procedure: COLPOSCOPY

CYTOLOGY

Active Comparator group

Description:

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

Treatment:

Device: cytology

Procedure: COLPOSCOPY