A prospective multicenter interventional study will be conducted to enroll women undergoing routine cervical cancer screening to collect cervical liquid-based cytology (LBC) specimen(s). For all subjects, two cervical specimens will be collected, and one placed into Hologic ThinPrep Pap Test collection kit with PreservCyt Solution (also referred to as ThinPrep specimen) and the other into BD SurePath liquid-based Pap test (also referred to as SurePath specimen). Cytology and HR HPV results will be generated and utilized to determine need for subject referral to colposcopy. Collection of an endocervical curettage (ECC) specimen, and biopsy(ies) if applicable, from women who are referred to colposcopy as a follow up will be conducted according to a standardized protocol. Disease status for each subject will be determined based on cytology, HPV test results, and/or consensus histology review of cervical biopsy specimens.
Study Type
OBSERVATIONAL
Enrollment
14,935
A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Desert Bloom Family Medicine / West Valley Research Clinic, LLC
Phoenix, Arizona, United States
Quality of Life Medical & Research Centers, LLC
Tucson, Arizona, United States
Visions Clinical Research
Tucson, Arizona, United States
Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3
Diagnosis of greater than or equal to CIN3 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.
Time frame: Baseline to 12 weeks
Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)
Diagnosis of greater than or equal to CIN2 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.
Time frame: Baseline to 12 weeks
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Northern California Research
Sacramento, California, United States
Physicians' Research Options
Lakewood, Colorado, United States
Planned Parenthood of Southern New England
New Haven, Connecticut, United States
David I Lubetkin, MD, LLC
Boca Raton, Florida, United States
Health Awareness INC
Jupiter, Florida, United States
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