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European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System

This study is currently recruiting participants.
Verified November 2012 by Becton, Dickinson and Company
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company
ClinicalTrials.gov Identifier:
NCT01671462
First received: July 13, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes

July 13, 2012
November 28, 2012
August 2012
May 2013   (final data collection date for primary outcome measure)
  • Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. [ Time Frame: Nine months ] [ Designated as safety issue: No ]
    Sensitivity is calculated: Number of subjects with positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with histology results of CIN2 or greater
  • Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. [ Time Frame: Nine months ] [ Designated as safety issue: No ]
    Specificity is calculated: Number of subjects with a negative BD HPV test and with histology results of less than CIN2 divided by the total number of subjects with histology results of less than CIN2.
  • 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. [ Time Frame: Nine months ] [ Designated as safety issue: No ]
    Positive Predictive Value is calculated: Number of subjects with a positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with a positive BD HPV test.
  • 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. [ Time Frame: Nine months ] [ Designated as safety issue: No ]
    Negative Predictive Value is calculated: Number of subjects with a negative result for the BD HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD HPV test.
Same as current
Complete list of historical versions of study NCT01671462 on ClinicalTrials.gov Archive Site
  • The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Positive percent agreement is calculated: The number of subjects with positive BD HPV test and positive results for the HC2 test and Roche Linear Array HPV divided by total of subjects with positive results for HC2 test and Roche Linear Array HPV.
  • Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test [ Time Frame: Nine months ] [ Designated as safety issue: No ]
    Negative percent agreement is calculated: The number of subjects with negative BD HPV test and negative results for the HC2 test and Roche Linear Array HPV divided by total of subjects with negative results for HC2 test and Roche Linear Array HPV test.
Same as current
Not Provided
Not Provided
 
European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System

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.

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.
Observational
Not Provided
Not Provided
Not Provided
Non-Probability Sample

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.
Uterine Cervical Neoplasms
Device: BD HPV assay on Viper LT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact: Karen Yanson, MS 410-316-4793 Karen_Yanson@bd.com
Contact: Salma Kodsi, MS 410-316-4502 Salma_Kodsi@bd.com
Denmark,   Italy
 
NCT01671462
MDX-11-EUHPV
No
Becton, Dickinson and Company
Becton, Dickinson and Company
Not Provided
Study Director: Irene Hannet, MD Becton, Dickinson and Company
Becton, Dickinson and Company
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP