Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening

Abbott

Status: Completed

Conditions: Human Papillomavirus

Treatments: Diagnostic Test: Alinity m HR HPV

Study type: Observational

Funder types: Industry

Identifiers

NCT04746872

V560-02-20S07-01

Details and patient eligibility

About

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.

Enrollment: 14,935 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

14,935 participants in 1 patient group

Alinity m HR HPV

Description:

The Alinity m HR HPV IUO assay is a qualitative in vitro test that amplifies and detects HR HPV DNA in cervical cells collected in liquid media. The assay can differentiate between HPV 16, HPV 18, HPV 45 and non-HPV 16/18/45 genotypes \[(31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68)\].

Treatment:

Diagnostic Test: Alinity m HR HPV