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

February 19, 2014 updated by: Becton, Dickinson and Company
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1365

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark
        • Hvidovre Hospital
  • Italy
      • Milan, Italy
        • European Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Nine months
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
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.
Nine months
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
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.
Nine months
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
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.
Nine months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
9 months
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
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.
Nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Becton, Dickinson and Company

Investigators

  • Study Director: Irene Hannet, MD, Becton, Dickinson and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 23, 2012

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX-11-EUHPV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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