Clinical trial NCT01671462: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cervical Neoplasms
Keywords: HPV
Cervical Cancer
Cervical Neoplasms
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 1365
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes retrospectively (residual, frozen) collected SurePath or PreservCyt vials and prospectively collected BD cervical brushes in BD transport medium, and SurePath or PreservCyt vials from subjects who meet the inclusion criteria below.

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 criteria: Inclusion Criteria:

* Referred to follow up due to one or more abnormal Pap or an HPV infection
* Subjects who have provided informed consent
* Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines.

Exclusion Criteria:

* Known to be pregnant
* With prior complete or partial hysterectomy involving removal of cervix
* Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds.
* Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.

Primary outcomes:
measure: Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
timeFrame: Nine months
measure: Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
timeFrame: Nine months
measure: Positive Predictive Value (PPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
timeFrame: Nine months
measure: Negative Predictive Value (NPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
timeFrame: Nine months
Secondary outcomes:
measure: The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test
timeFrame: 9 months
measure: Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test
timeFrame: Nine months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: Becton, Dickinson and Company
name: Irene Hannet, MD
role: STUDY_DIRECTOR
References:
citation: Ejegod DM, Junge J, Franzmann M, Kirschner B, Bottari F, Sideri M, Sandri MT, Bonde J. Clinical and analytical performance of the BD Onclarity HPV assay for detection of CIN2+ lesions on SurePath samples. Papillomavirus Res. 2016 Dec;2:31-37. doi: 10.1016/j.pvr.2016.01.003. Epub 2016 Mar 2.
citation: Ejegod DM, Rebolj M, Bonde J. Comparison of analytical and clinical performance of CLART HPV2 genotyping assay to Linear Array and Hybrid Capture 2: a split-sample study. BMC Cancer. 2015 Apr 2;15:216. doi: 10.1186/s12885-015-1223-z.