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

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.

Study Overview

• Status: Terminated
• Conditions: Uterine Cervical Neoplasm
• Intervention / Treatment: Procedure: Colposcopy/biopsy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Outremont, Quebec, Canada, H2V 3J11
      • BioVision
• United States
  • Colorado
    • Denver, Colorado, United States, 80207
      • Planned Parenthood of the Rocky Mountains
    • Denver, Colorado, United States, 80222
      • American Pathology Partners Inc.
  • Florida
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials, Llc
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46202
      • Sidney & Lois Eskenazi Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68164
      • Transgenomics
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Southwest Womens Health
    • Albuquerque, New Mexico, United States, 87102
      • Tricore Reference Lab
  • New York
    • Irvington, New York, United States, 10533
      • Research Pathology Associates, LLC
  • North Carolina
    • Charlotte, North Carolina, United States, 22901
      • Research Pathology Associates
  • Texas
    • San Antonio, Texas, United States, 78233
      • Center for Disease Detection

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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. 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.

Procedure: Colposcopy/biopsy; Colposcopy/biopsy will be performed on all subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months
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.	18 months
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.	18 months
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.	18 Months
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.	18 months
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.	18 Months
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.	18 Months
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.	18 Months
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.	18 months
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	18 months

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: BDS-USHPVPC-AC