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

NCT01944722 | Completed Results

• 1 other identifier: BDS-USHPV
• Study Type: interventional
• Target: 33,858
• Locations: 1 country
• Sites: 41

Brief Summary

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.

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (1)

BD Onclarity™ HPV assay on BD Viper™ LT

EXPERIMENTAL

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; Procedure: Colposcopy

Interventions

BD Onclarity™ HPV assay on BD Viper™ LT DEVICE

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.

BD Onclarity™ HPV assay on BD Viper™ LT

Colposcopy PROCEDURE

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.

BD Onclarity™ HPV assay on BD Viper™ LT

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (41)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Mobile OB/GYN

Mobile, Alabama, 36608, United States

Location

Women's Health Research of Arizona

Phoenix, Arizona, 85015, United States

Location

Quality of Life Medical & Research Center

Tucson, Arizona, 85712, United States

Location

Visions Clinical Research

Tucson, Arizona, 85712, United States

Location

Women's Health Care Research Corp

San Diego, California, 92111, United States

Location

West Coast Medical Research

San Diego, California, 92123, United States

Location

Blueskies Center for Women

Colorado Springs, Colorado, 80910, United States

Location

Health Awareness Inc

Jupiter, Florida, 33458, United States

Location

Altus

Lake Worth, Florida, 33461, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Medical Network for Education and Research

Decatur, Georgia, 30033, United States

Location

Fellows Research Associates - Savannah

Savannah, Georgia, 31406, United States

Location

Women's Health Practice

Champaign, Illinois, 61820, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

Saginaw Valley Medical Research

Saginaw, Michigan, 48604, United States

Location

Transgenomics

Omaha, Nebraska, 68164, United States

Location

Vitura / Phoenix

Moorestown, New Jersey, 08057, United States

Location

Meridian Health

Neptune City, New Jersey, 07753, United States

Location

Q Squared Solutions

Teterboro, New Jersey, 07608, United States

Location

TriCore Reference Laboratory

Albuquerque, New Mexico, 87102, United States

Location

Research Pathology Associates, LLC

Irvington, New York, 10533, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

LabCorp

Burlington, North Carolina, 27215, United States

Location

Eastern Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

HWC Women's Research Center

Englewood, Ohio, 45322, United States

Location

Center for Women's Health of Lansdale

Lansdale, Pennsylvania, 19446, United States

Location

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

Reading Health Physicians Network

West Reading, Pennsylvania, 19611, United States

Location

Fellows Research Associates - Bluffton

Bluffton, South Carolina, 29910, United States

Location

James T Martin Jr, MD

North Charleston, South Carolina, 29406, United States

Location

Chattanooga Medical Research

Chattanooga, Tennessee, 37404, United States

Location

Center for Disease Detection (CDD)

San Antonio, Texas, 78233, United States

Location

Physicians Research Options

Draper, Utah, 84020, United States

Location

Research Pathology Associates

Earlysville, Virginia, 22936, United States

Location

Tidewater Clinical

Virginia Beach, Virginia, 23456, United States

Location

Related Publications (3)

• 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.

  PMID: 30649177 DERIVED

• 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.

  PMID: 30189049 DERIVED

• 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.

  PMID: 29681462 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Becton, Dickinson and Company

BDClinicalTrials@bd.com

410-316-4000

Study Officials

• Charles Cooper, MD

  Becton, Dickinson and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 18, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 12, 2018
• Results First Posted: April 18, 2018

Record last verified: 2018-05

Locations

US (41)