Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens
Device Data
Collected from past medical records and data - RetrospectiveUrogenital Diseases+21
+ Genital Diseases
+ Uterine Cervical Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System in cervical cancer screening. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Subjects who were previously enrolled into the prospective, multicenter US clinical study for the APTIMA HPV Assay on the TIGRIS System (protocol 2007HPVASCUS30) will be eligible for inclusion in the study of the AHPV-GT Assay using the PANTHER System described in this protocol. All evaluable ASC-US Study subjects ≥21 years of age will be eligible for inclusion. 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: Eligible subjects will be excluded if they do not have an evaluable sample. This may be due to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Hennepin County Medical Center
Minneapolis, United StatesOpen Hennepin County Medical Center in Google MapsLaboratory Corporation of America
Burlington, United StatesMolecular Pathology Laboratory Network, Inc
Maryville, United States