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

Human Papillomavirus Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04746872
Study type Observational
Source Abbott Molecular
Contact
Status Completed
Phase
Start date February 16, 2021
Completion date November 3, 2022
View Details
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