At a glance
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Evaluation of Strategies for Optimal Clinical Management of Women With Atypical Squamous Cells of Undetermined Significance (ASC-US)
In Brief
A clinical study evaluating HPV test, COLPOSCOPY, and 1 other intervention for Cervical Abnormalities and 2 related conditions. Completed, enrolled 2,661 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
QIAGEN - The Digene HPV test®
Colposcopy routine health services
Cytology routine health services