Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746872
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2021-02-05
Brief Title:
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Sponsor:
Abbott Molecular
Organization:
Abbott Molecular
Study Overview
Official Title:
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 specimens 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 biopsyies 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 andor consensus histology review of cervical biopsy specimens
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None