Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
NCT ID: NCT03020121
Last Updated: 2018-01-31
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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TERMINATED
NA
28 participants
INTERVENTIONAL
2016-11-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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. 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.
Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the 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/biopsy will be performed on all subjects.
Colposcopy/biopsy
Colposcopy/biopsy will be performed on all subjects
Interventions
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Colposcopy/biopsy
Colposcopy/biopsy will be performed on all subjects
Eligibility Criteria
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Inclusion Criteria
* Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology result,
* Females who provide informed consent
Exclusion Criteria
* Prior complete or partial hysterectomy involving removal of cervix
* Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
* Colposcopy clinic referral patients
21 Years
FEMALE
Yes
Sponsors
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Becton, Dickinson and Company
INDUSTRY
Responsible Party
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Locations
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Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States
American Pathology Partners Inc.
Denver, Colorado, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Transgenomics
Omaha, Nebraska, United States
Southwest Womens Health
Albuquerque, New Mexico, United States
Tricore Reference Lab
Albuquerque, New Mexico, United States
Research Pathology Associates, LLC
Irvington, New York, United States
Research Pathology Associates
Charlotte, North Carolina, United States
Center for Disease Detection
San Antonio, Texas, United States
BioVision
Outremont, Quebec, Canada
Countries
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Other Identifiers
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BDS-USHPVPC-AC
Identifier Type: -
Identifier Source: org_study_id