Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
Human Papillomavirus Infection
About this trial
This is an interventional screening trial for Human Papillomavirus Infection focused on measuring Cervix Cancer, Cervical Intraepithelial Neoplasia (CIN), Human Papillomavirus Virus (HPV), APTIMA HPV Assay, FDA-Approved HPV DNA Test, TIGRIS DTS (direct tube sampling) System, Clinical Sensitivity (%), Clinical Specificity (%), Positive Predictive Value [PPV] (%), Negative Predictive Value [NPV] (%), Atypical Squamous Cells Undetermined Significance (ASC-US), Relative Risk
Eligibility Criteria
Inclusion Criteria:
- Female 21 years or older (ASC-US study only)
- Female 30 years or older (Adjunct and ASC-US studies)
- Subject attending a participating clinic and undergoing a Pap screening exam during the clinic visit
- Ability to comprehend and sign an IRB-approved Informed Consent Form
Exclusion Criteria:
- Diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months
- Abnormal Pap test result in the past 12 months
- Subject under 18 years of age and consenting to the study without the presence of their parent or legal guardian
- Known to be pregnant
- Having an illness or medical condition that could interfere with or affect the conduct, results, and/or completion of the clinical trial
- Having an illness or medical condition that the investigator or physician feels would create an unacceptable risk to the subject if she enrolled into the clinical trial
- Prior vaccination for HPV
Sites / Locations
- NEA Clinic Women's Clinic
- San Fernando Valley Research
- Healthcare Partners of Monterey Park
- Diverse Research Solutions
- REMEK
- West Coast OB-Gyn
- HealthCare Partners
- Penninsula Research Associates
- Community Medical Research of South Florida
- Insignia Clinical Research
- Emory University School of Medicine
- Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences
- Saginaw Valley Medical Research
- PPS Clinical
- Planned Parenthood of Eastern Arkansas and Oklahoma
- Temple University Hospital
- Adams Patterson OB-GYN
Arms of the Study
Arm 1
Arm 2
Other
Other
Adjunct (i.e. Normal Pap)
ASC-US
The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period. A comparator FDA-Approved HPV DNA test is reported.
The ASC-US study will evaluate the APTIMA HPV Assay clinical performance for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results). A comparator FDA-Approved HPV DNA test is reported. There is no follow-up period.