Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator.

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Device: BD Onclarity™ HPV assay on BD Viper™ LT; Procedure: Colposcopy

• Study Type: Interventional
• Enrollment (Actual): 33858
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Birmingham
    • Mobile, Alabama, United States, 36608
      • Mobile OB/GYN
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Women's Health Research of Arizona
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical & Research Center
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research
  • California
    • San Diego, California, United States, 92111
      • Women's Health Care Research Corp
    • San Diego, California, United States, 92123
      • West Coast Medical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Blueskies Center for Women
  • Florida
    • Jupiter, Florida, United States, 33458
      • Health Awareness Inc
    • Lake Worth, Florida, United States, 33461
      • Altus
    • North Miami, Florida, United States, 33161
      • Segal Institute for Clinical Research
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials, Llc
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Medical Network for Education and Research
    • Savannah, Georgia, United States, 31406
      • Fellows Research Associates - Savannah
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Women's Health Practice
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68164
      • Transgenomics
  • New Jersey
    • Moorestown, New Jersey, United States, 08057
      • Vitura / Phoenix
    • Neptune, New Jersey, United States, 07753
      • Meridian Health
    • Teterboro, New Jersey, United States, 07608
      • Q Squared Solutions
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • TriCore Reference Laboratory
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Irvington, New York, United States, 10533
      • Research Pathology Associates, LLC
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • LabCorp
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
  • Ohio
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Center for Women's Health of Lansdale
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia
    • West Reading, Pennsylvania, United States, 19611
      • Reading Health Physicians Network
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • Fellows Research Associates - Bluffton
    • North Charleston, South Carolina, United States, 29406
      • James T Martin Jr, MD
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research
  • Texas
    • San Antonio, Texas, United States, 78233
      • Center for Disease Detection (CDD)
  • Utah
    • Draper, Utah, United States, 84020
      • Physicians Research Options
  • Virginia
    • Earlysville, Virginia, United States, 22936
      • Research Pathology Associates
    • Virginia Beach, Virginia, United States, 23456
      • Tidewater Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females who are >21 years of age
• Females who provide informed consent

Exclusion Criteria:

• Known pregnant
• Cervical cytology specimen collected within the last 4 months
• Prior complete or partial hysterectomy involving removal of cervix
• Application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications
• Conization, Loop Electrosurgical Excision Procedure (LEEP), cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
• Enrolled in a cervical disease diagnostic trial since 2007.

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 Onclarity™ HPV assay on BD Viper™ LT; The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. Colposcopy will be performed on subjects who have abnormal cytology or HPV positive test results or from a random sampling of subjects with normal cytology and HPV negative test results.

Device: BD Onclarity™ HPV assay on BD Viper™ LT; The BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD 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.; Procedure: Colposcopy; Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater	Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ 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 (multiplied by 100).	Up to 14 weeks
Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater	Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of CIN3 or greater (multiplied by 100).	Up to 14 weeks
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater	Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of less than CIN2 (multiplied by 100).	Up to 14 weeks
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater	Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of less than CIN3 (multiplied by 100).	Up to 14 weeks
Positive Predictive Value (PPV) of the BD Onclarity™ 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 Onclarity™ HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.	Up to 14 weeks
Negative Predictive Value (NPV) of the BD Onclarity™ 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 Onclarity™ HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.	Up to 14 weeks
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).	The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN2 or greater disease are to have that particular BD HPV Onclarity™ test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.	Up to 14 weeks
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).	The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN3 or greater disease are to have that particular BD Onclarity™ HPV test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.	Up to 14 weeks
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).	The Absolute Risk (AR) of CIN2 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.	Up to 14 weeks
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).	The Absolute Risk (AR) of CIN3 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.	Up to 14 weeks
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).	Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN2 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.	Up to 14 weeks
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).	Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN3 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.	Up to 14 weeks
Positive Percent Agreement of the BD Onclarity™ 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 Onclarity™ HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive (multiplied by 100).	Up to 14 weeks
Negative Percent Agreement of the BD Onclarity™ HPV Assay Compared to a Composite HPV Comparator Incorporating Results for the Digene HC2 HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)	Negative percent agreement is calculated: Number of subjects with a negative BD Onclarity™ HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative (multiplied by 100).	Up to 14 weeks
Non-reportable Rate of the BD Onclarity™ HPV Test	Non-reportable rate is calculated as the number of non-reportable BD Onclarity™ HPV test results divided by the total number of BD Onclarity™ HPV test results (multiplied by 100). Not included in this calculation are specimens that did not yield a result due to specimen labeling, processing and volume issues.	Up to 14 weeks
Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.	Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.	Up to 14 weeks

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Study Director: Charles Cooper, MD, Becton, Dickinson and Company

Publications and helpful links

General Publications

• Stoler MH, Wright TC, Parvu V, Yanson K, Eckert K, Kodsi S, Cooper C. HPV Testing With 16, 18, and 45 Genotyping Stratifies Cancer Risk for Women With Normal Cytology. Am J Clin Pathol. 2019 Mar 1;151(4):433-442. doi: 10.1093/ajcp/aqy169.
• Wright TC Jr, Stoler MH, Parvu V, Yanson K, Eckert K, Kodsi S, Cooper CK. Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance Population: Results of the Becton Dickinson Onclarity Trial. Am J Clin Pathol. 2019 Jan 1;151(1):53-62. doi: 10.1093/ajcp/aqy084.
• Stoler MH, Wright TC Jr, Parvu V, Vaughan L, Yanson K, Eckert K, Karchmer T, Kodsi S, Cooper CK. The Onclarity Human Papillomavirus Trial: Design, methods, and baseline results. Gynecol Oncol. 2018 Jun;149(3):498-505. doi: 10.1016/j.ygyno.2018.04.007. Epub 2018 Apr 19.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 13, 2013
• First Posted (Estimate): September 18, 2013

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 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-USHPV