Clinical trial NCT01944722: Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Official title: Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2013-09-18
Enrollment: 33858
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
timeFrame: Up to 14 weeks
measure: Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater
timeFrame: Up to 14 weeks
measure: Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
timeFrame: Up to 14 weeks
measure: Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater
timeFrame: Up to 14 weeks
measure: Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).
timeFrame: Up to 14 weeks
measure: Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).
timeFrame: Up to 14 weeks
measure: Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
timeFrame: Up to 14 weeks
measure: Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
timeFrame: Up to 14 weeks
measure: Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
timeFrame: Up to 14 weeks
measure: Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
timeFrame: Up to 14 weeks
measure: Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
timeFrame: Up to 14 weeks
measure: Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
timeFrame: Up to 14 weeks
measure: 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)
timeFrame: Up to 14 weeks
measure: 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)
timeFrame: Up to 14 weeks
measure: Non-reportable Rate of the BD Onclarity™ HPV Test
timeFrame: Up to 14 weeks
measure: Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.
timeFrame: Up to 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Mobile
country: United States
facility: Mobile OB/GYN
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research of Arizona
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: San Diego
country: United States
facility: Women's Health Care Research Corp
state: California
city: San Diego
country: United States
facility: West Coast Medical Research
state: California
city: Colorado Springs
country: United States
facility: Blueskies Center for Women
state: Colorado
city: Jupiter
country: United States
facility: Health Awareness Inc
state: Florida
city: Lake Worth
country: United States
facility: Altus
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Decatur
country: United States
facility: Medical Network for Education and Research
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Associates - Savannah
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research
state: Michigan
city: Omaha
country: United States
facility: Transgenomics
state: Nebraska
city: Moorestown
country: United States
facility: Vitura / Phoenix
state: New Jersey
city: Neptune
country: United States
facility: Meridian Health
state: New Jersey
city: Teterboro
country: United States
facility: Q Squared Solutions
state: New Jersey
city: Albuquerque
country: United States
facility: TriCore Reference Laboratory
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Irvington
country: United States
facility: Research Pathology Associates, LLC
state: New York
city: Burlington
country: United States
facility: LabCorp
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Lansdale
country: United States
facility: Center for Women's Health of Lansdale
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Health Physicians Network
state: Pennsylvania
city: Bluffton
country: United States
facility: Fellows Research Associates - Bluffton
state: South Carolina
city: North Charleston
country: United States
facility: James T Martin Jr, MD
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research
state: Tennessee
city: San Antonio
country: United States
facility: Center for Disease Detection (CDD)
state: Texas
city: Draper
country: United States
facility: Physicians Research Options
state: Utah
city: Earlysville
country: United States
facility: Research Pathology Associates
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical
state: Virginia
Study officials:
affiliation: Becton, Dickinson and Company
name: Charles Cooper, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.