Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
NCT ID: NCT01944722
Last Updated: 2018-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
33858 participants
INTERVENTIONAL
2013-08-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Females who provide informed consent
Exclusion Criteria
* 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.
21 Years
FEMALE
Yes
Sponsors
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Becton, Dickinson and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Charles Cooper, MD
Role: STUDY_DIRECTOR
Becton, Dickinson and Company
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Mobile OB/GYN
Mobile, Alabama, United States
Women's Health Research of Arizona
Phoenix, Arizona, United States
Quality of Life Medical & Research Center
Tucson, Arizona, United States
Visions Clinical Research
Tucson, Arizona, United States
Women's Health Care Research Corp
San Diego, California, United States
West Coast Medical Research
San Diego, California, United States
Blueskies Center for Women
Colorado Springs, Colorado, United States
Health Awareness Inc
Jupiter, Florida, United States
Altus
Lake Worth, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Medical Network for Education and Research
Decatur, Georgia, United States
Fellows Research Associates - Savannah
Savannah, Georgia, United States
Women's Health Practice
Champaign, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Four Rivers Clinical Research
Paducah, Kentucky, United States
Louisiana State University
New Orleans, Louisiana, United States
Saginaw Valley Medical Research
Saginaw, Michigan, United States
Transgenomics
Omaha, Nebraska, United States
Vitura / Phoenix
Moorestown, New Jersey, United States
Meridian Health
Neptune City, New Jersey, United States
Q Squared Solutions
Teterboro, New Jersey, United States
TriCore Reference Laboratory
Albuquerque, New Mexico, United States
Research Pathology Associates, LLC
Irvington, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
LabCorp
Burlington, North Carolina, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
HWC Women's Research Center
Englewood, Ohio, United States
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
Reading Health Physicians Network
West Reading, Pennsylvania, United States
Fellows Research Associates - Bluffton
Bluffton, South Carolina, United States
James T Martin Jr, MD
North Charleston, South Carolina, United States
Chattanooga Medical Research
Chattanooga, Tennessee, United States
Center for Disease Detection (CDD)
San Antonio, Texas, United States
Physicians Research Options
Draper, Utah, United States
Research Pathology Associates
Earlysville, Virginia, United States
Tidewater Clinical
Virginia Beach, Virginia, United States
Countries
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References
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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.
Other Identifiers
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BDS-USHPV
Identifier Type: -
Identifier Source: org_study_id
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