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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
  Purpose

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.


Condition Intervention
Uterine Cervical Neoplasms
 Device: BD HPV assay on Viper LT

Study Type: Observational
Official Title: European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Becton, Dickinson and Company:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1400
Study Start Date: August 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Female
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671462

Contacts
Contact: Karen Yanson, MS 410-316-4793 Karen_Yanson@bd.com
Contact: Salma Kodsi, MS 410-316-4502 Salma_Kodsi@bd.com

Locations
Denmark
Hvidovre Hospital Recruiting
Hvidovre, Denmark
Principal Investigator: Jesper Bonde, Ph.D.            
Italy
European Institute of Oncology Recruiting
Milan, Italy
Principal Investigator: Mario Sideri, MD            
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
Study Director: Irene Hannet, MD Becton, Dickinson and Company
  More Information

No publications provided

Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT01671462     History of Changes
Other Study ID Numbers: MDX-11-EUHPV
Study First Received: July 13, 2012
Last Updated: November 28, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Becton, Dickinson and Company:
HPV
Cervical Cancer
Cervical Neoplasms

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 17, 2013