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

• Sponsor: Becton, Dickinson and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01671462
• Collaborator: (none)
• Enrollment: 1,365
• Locations: 2
• Duration (Months): 15
• Patients Per Site: 682.5
• Patients Per Site Per Month: 45.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasms	Device: BD HPV assay on Viper LT

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 Design

• Study Type: Observational
• Actual Enrollment: 1365 participants
• Official Title: European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Outcome Measures

Primary Outcome Measures

1. Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. [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

2. Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. [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.

3. 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. [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.

4. 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. [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.

Secondary Outcome Measures

1. The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test [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.

2. Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre Hospital	Hvidovre		Denmark
2	European Institute of Oncology	Milan		Italy

Sponsors and Collaborators

• Becton, Dickinson and Company

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Becton, Dickinson and Company
• ClinicalTrials.gov Identifier: NCT01671462
• Other Study ID Numbers: MDX-11-EUHPV
• First Posted: Aug 23, 2012
• Last Update Posted: Feb 20, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Becton, Dickinson and Company: HPV; Cervical Cancer; Cervical Neoplasms
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of Feb 20, 2014