Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
NCT ID: NCT01694875
Last Updated: 2012-11-14
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
2200 participants
OBSERVATIONAL
2012-10-31
2012-11-30
Brief Summary
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This objective will be accomplished in the ASC-US Study by evaluating the performance characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women with ASC-US Pap test results who were 21 years of age or older ("≥21 years of age") at the time of their Pap visit. For the Adjunct Study, this objective will be accomplished by evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at increased risk of cervical disease in a sample population of women with negative (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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No Treatment
APTIMA HPV Assay
In Vitro Diagnostics Assay
Interventions
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APTIMA HPV Assay
In Vitro Diagnostics Assay
Eligibility Criteria
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Inclusion Criteria
Evaluable Adjunct Study subjects ≥30 years of age will be eligible if the following criteria are met:
* the subject attended the colposcopy visit, or
* the subject did not attend the colposcopy visit but the referral Pap sample had a positive APTIMA HPV Assay result in the APTIMA HPV Assay TIGRIS System study (protocol 2007HPVASCUS30) or in the APTIMA HPV Assay PANTHER System study (protocol AHPVPS-US11-003).
Exclusion Criteria
21 Years
FEMALE
Yes
Sponsors
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Gen-Probe, Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer L Reid, PhD
Role: STUDY_DIRECTOR
Gen-Probe, Incorporated
Locations
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Hennepin County Medical Center
Minneapolis, Minnesota, United States
Laboratory Corporation of America
Burlington, North Carolina, United States
Molecular Pathology Laboratory Network, Inc
Maryville, Tennessee, United States
Countries
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Other Identifiers
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HPVGPS-US12-001
Identifier Type: -
Identifier Source: org_study_id