Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
NCT ID: NCT02267876
Last Updated: 2021-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6730 participants
OBSERVATIONAL
2014-10-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BD VIPER LT
BD HPV Assay on Viper LT
The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.
Colposcopy
The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.
Interventions
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BD HPV Assay on Viper LT
The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.
Colposcopy
The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
* Year 3 visit can not exceed 3 years and 6 months from the baseline visit
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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Tobi Karchmer, MD
Role: STUDY_DIRECTOR
Becton, Dickinson and Company
Locations
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University of Alabama
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
Blueskies Center for Women
Colorado Springs, Colorado, United States
Health Awareness Inc.
Jupiter, Florida, United States
Altus Research
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 Trails, LLC
West Palm Beach, Florida, United States
Medical Network for Education & Research
Decatur, Georgia, United States
Fellows Research Alliance - 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
BD 54 Loveton
Sparks, Maryland, United States
Saginaw Valley Medical Research
Saginaw, Michigan, United States
Virtua Phoenix OB/GYN
Moorestown, New Jersey, United States
Meridian Health / Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Quest Laboratories
Teterboro, New Jersey, United States
TriCore
Albuquerque, New Mexico, United States
Research Pathology Associates, LLC
Irvington, New York, United States
Montefiore Medical Center
The Bronx, New York, 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 Physician Network
West Reading, Pennsylvania, United States
Fellows Research Alliance - Bluffton
Bluffton, South Carolina, United States
James T. Martin Jr. OB/GYN
North Charleston, South Carolina, United States
Chattanooga Medical Research
Chattanooga, Tennessee, United States
Center for Disease Detection, LLC
San Antonio, Texas, United States
Physicians Research Options
Draper, Utah, United States
Research Pathology Associates
Charlottesville, Virginia, United States
Tidewater Clinical Research
Virginia Beach, Virginia, United States
BioVision
Montreal, Quebec, Canada
Countries
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Other Identifiers
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BDS-USLHPV
Identifier Type: -
Identifier Source: org_study_id
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