Human Papillomavirus
Conditions
Keywords
HPV, Virus, Cervical, Cancer, Oncology, Screening, tissue collection, biopsy
Brief summary
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.
Interventions
DIAGNOSTIC_TESTAlinity m HR HPV
A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.
Sponsors
Abbott Molecular
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women is eligible if she meets the following: * Is 25 years of age or older * Is attending a participating clinic for routine cervical cancer screening following screening guidelines * Has an intact cervix * Is willing and able to provide documented informed consent * Is willing and able to undergo colposcopy, biopsy, and endocervical curettage (ECC) within 12 weeks (≤ 84 days) from the baseline visit, if required * Is willing and able to allow collection of two cervical cytology specimens
Exclusion criteria
A women is ineligible for the study if she meets any of the following criteria: * Is pregnant at the time of visit or plans to become pregnant within the following 12 weeks * Has any known medical condition that, in the opinion of the investigator, would result in increased risk of bleeding at biopsy * Has a known history of excisional or ablative therapy (e.g., LEEP, cone biopsy, cervical laser surgery, or cryotherapy) to the cervix in the last 12 months prior to the baseline visit * Had a cervical cytology specimen collected within the last 4 months * Is currently participating in any diagnostic trial for cervical cancer * Had a complete or partial hysterectomy, either supra cervical or involving removal of the cervix * Is currently participating or planning to participate in any clinical trial for HPV treatment (for the duration of this study) * Previous participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3 | Baseline to 12 weeks | Diagnosis of greater than or equal to CIN3 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2) | Baseline to 12 weeks | Diagnosis of greater than or equal to CIN2 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result. |
Countries
United States
Outcome results
None listed