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Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

Primary Purpose

Uterine Cervical Neoplasm

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Colposcopy/biopsy
Sponsored by
Becton, Dickinson and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Cervical Neoplasm

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females who are greater than or equal to 21 years of age,
  • Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology result,
  • Females who provide informed consent

Exclusion Criteria:

  • Known pregnant
  • Prior complete or partial hysterectomy involving removal of cervix
  • Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
  • Colposcopy clinic referral patients

Sites / Locations

  • Planned Parenthood of the Rocky Mountains
  • American Pathology Partners Inc.
  • Comprehensive Clinical Trials, LLC
  • Indiana University
  • Sidney & Lois Eskenazi Hospital
  • Transgenomics
  • Southwest Womens Health
  • Tricore Reference Lab
  • Research Pathology Associates, LLC
  • Research Pathology Associates
  • Center for Disease Detection
  • BioVision

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BD HPV assay on Viper LT

Arm Description

The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Colposcopy/biopsy will be performed on all subjects.

Outcomes

Primary Outcome Measures

Sensitivity
Sensitivity of the BD HPV Assay for the detection of cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Sensitivity is calculated: Number of subjects with a positive BD HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater. Similar for CIN3 or greater.
Specificity
Specificity of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Specificity is calculated: Number of subjects with a negative BD HPV test with adjudicated histology results of less than CIN2 divided by the total number of subjects with adjudicated histology results of less than CIN2. Similar for CIN3 or greater.
PositivePredictive Value
Positive Predictive Value (PPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Positive Predictive Value is calculated: Number of subjects with a positive result for the BD HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD HPV test. Similar for CIN3 or greater.
Negative Predictive Value
Negative Predictive Value (NPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). 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. Similar for CIN3 or greater.
Likelyhood ratio
Likelihood ratio for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The likelihood ratio for each BD HPV test outcome summarizes how many times more (or less) likely subjects with the disease (e.g. CIN2 or greater and CIN3 or greater) are to have that particular HPV test outcome than subjects without the disease.
Absolute Risk
Absolute risk for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The Absolute Risk (AR) of the disease(e.g., CIN2 or greater and CIN3 or greater) for each BD HPV test outcome is the probability of the disease for that particular BD HPV test outcome.
Relative Risk
Relative Risk of the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). Relative Risk is the ratio between two different absolute risks. The relative risk of having a disease (e.g., CIN2 or greater and CIN3 or greater), will be evaluated to compare two different BD HPV Assay test outcomes.
Positive Percent Agreement
Positive percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene Hybrid Capture 2 (HC2) HPV test and PCR/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Positive percent agreement is calculated: Number of subjects with a positive BD HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive.
Negative PercentAgreement
Negative percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene HC2 HPV test and Polymerase Chain Reaction (PCR)/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Negative percent agreement is calculated: Number of subjects with a negative BD HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative.
Non reportable rate
.Non-reportable rate of BD HPV test. Non-reportable rate is calculated as the number of non-reportable BD HPV test results divided by the total number of BD HPV test results

Secondary Outcome Measures

Full Information

First Posted
January 11, 2017
Last Updated
January 29, 2018
Sponsor
Becton, Dickinson and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03020121
Brief Title
Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
Official Title
Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Lower than anticipated rate of subject enrollment
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Becton, Dickinson and Company

4. Oversight

Data Monitoring Committee
No

5. 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 Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BD HPV assay on Viper LT
Arm Type
Experimental
Arm Description
The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Colposcopy/biopsy will be performed on all subjects.
Intervention Type
Procedure
Intervention Name(s)
Colposcopy/biopsy
Intervention Description
Colposcopy/biopsy will be performed on all subjects
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity of the BD HPV Assay for the detection of cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Sensitivity is calculated: Number of subjects with a positive BD HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater. Similar for CIN3 or greater.
Time Frame
18 months
Title
Specificity
Description
Specificity of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Specificity is calculated: Number of subjects with a negative BD HPV test with adjudicated histology results of less than CIN2 divided by the total number of subjects with adjudicated histology results of less than CIN2. Similar for CIN3 or greater.
Time Frame
18 months
Title
PositivePredictive Value
Description
Positive Predictive Value (PPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Positive Predictive Value is calculated: Number of subjects with a positive result for the BD HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD HPV test. Similar for CIN3 or greater.
Time Frame
18 months
Title
Negative Predictive Value
Description
Negative Predictive Value (NPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). 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. Similar for CIN3 or greater.
Time Frame
18 Months
Title
Likelyhood ratio
Description
Likelihood ratio for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The likelihood ratio for each BD HPV test outcome summarizes how many times more (or less) likely subjects with the disease (e.g. CIN2 or greater and CIN3 or greater) are to have that particular HPV test outcome than subjects without the disease.
Time Frame
18 months
Title
Absolute Risk
Description
Absolute risk for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The Absolute Risk (AR) of the disease(e.g., CIN2 or greater and CIN3 or greater) for each BD HPV test outcome is the probability of the disease for that particular BD HPV test outcome.
Time Frame
18 Months
Title
Relative Risk
Description
Relative Risk of the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). Relative Risk is the ratio between two different absolute risks. The relative risk of having a disease (e.g., CIN2 or greater and CIN3 or greater), will be evaluated to compare two different BD HPV Assay test outcomes.
Time Frame
18 Months
Title
Positive Percent Agreement
Description
Positive percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene Hybrid Capture 2 (HC2) HPV test and PCR/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Positive percent agreement is calculated: Number of subjects with a positive BD HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive.
Time Frame
18 Months
Title
Negative PercentAgreement
Description
Negative percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene HC2 HPV test and Polymerase Chain Reaction (PCR)/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Negative percent agreement is calculated: Number of subjects with a negative BD HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative.
Time Frame
18 months
Title
Non reportable rate
Description
.Non-reportable rate of BD HPV test. Non-reportable rate is calculated as the number of non-reportable BD HPV test results divided by the total number of BD HPV test results
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females who are greater than or equal to 21 years of age, Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology result, Females who provide informed consent Exclusion Criteria: Known pregnant Prior complete or partial hysterectomy involving removal of cervix Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months Colposcopy clinic referral patients
Facility Information:
Facility Name
Planned Parenthood of the Rocky Mountains
City
Denver
State/Province
Colorado
ZIP/Postal Code
80207
Country
United States
Facility Name
American Pathology Partners Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sidney & Lois Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Transgenomics
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68164
Country
United States
Facility Name
Southwest Womens Health
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Tricore Reference Lab
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Research Pathology Associates, LLC
City
Irvington
State/Province
New York
ZIP/Postal Code
10533
Country
United States
Facility Name
Research Pathology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
22901
Country
United States
Facility Name
Center for Disease Detection
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
BioVision
City
Outremont
State/Province
Quebec
ZIP/Postal Code
H2V 3J11
Country
Canada

12. IPD Sharing Statement

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Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

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