Spots Global Cancer Trial Database for European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
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Trial Identification
Brief Title: European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
Official Title: European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
Study ID: NCT01671462
Conditions
Interventions
Study Description
Brief Summary: The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.
Detailed Description: This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD Viper LT Systems. The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping Test results.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hvidovre Hospital, Hvidovre, , Denmark
European Institute of Oncology, Milan, , Italy
Contact Details
Name: Irene Hannet, MD
Affiliation: Becton, Dickinson and Company
Role: STUDY_DIRECTOR
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