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Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit

Becton, Dickinson and Company · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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cervical-cancer
The objective of this study is to verify the clinical effectiveness of HPV Genotyping Nucleic Acid Assay Kit. This is a multi-center clinical study involving at least three study centers, each with screening sites. The protocol describes two study phases: Phase I is a baseline study of the screened population and ASCUS referral population (if necessary), the data of which will be submitted after the baseline study is completed; Phase II is a three-year follow-up study of the screened population, the data of which will be submitted again after the follow-up is completed.
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