NCT04746872

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14,935 (actual)
• Sponsor: Abbott Molecular · Industry
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Papillomavirus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Alinity m HR HPV	A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-06-16
• Completion: 2022-11-03
• First posted: 2021-02-10
• Last updated: 2024-02-12

Locations

63 sites across 1 country: United States

Regulatory

• FDA-regulated device study