Spots Global Cancer Trial Database for Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
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Trial Identification
Brief Title: Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
Official Title: 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
Study ID: NCT01694875
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
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
Contact Details
Name: Jennifer L Reid, PhD
Affiliation: Gen-Probe, Incorporated
Role: STUDY_DIRECTOR
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