Ignite Creation Date:
2024-05-06 @ 7:56 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02634190
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2015-12-03
Brief Title:
Clinical Evaluation of the APTIMA HPV Assay and Comparison With the HR HC2 Test Using LBC ThinPrep Specimens
Sponsor:
Hologic Deutschland GmbH
Organization:
Hologic Deutschland GmbH
Study Overview
Official Title:
Clinical Evaluation of the APTIMA HPV Assay and Comparison With the HR HPV HC2 Test in Women 30 Years of Age or Older Using LBC ThinPrep Pap Test Specimens
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:
To assess and compare the performance of the HR HPV HC2 test QiagenDigene and the APTIMA HPV Assay Hologic using LBC Specimens ThinPrep Pap Test for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany
Detailed Description:
The study is conducted in the areas of Tuebingen Freiburg and Saarbruecken in Germany In total 10000 ThinPrep LBC cervical samples were collected from June 2009 to May 2012 Liquid based cytology LBC was performed by a central laboratory in Saarbruecken Human papilloma virus HPV testing with the HR HPV HC2 test and APTIMA HPV Assay were performed at the Section of Experimental Virology Institute of Medical Virology University Clinic of Tuebingen Germany UKT
Within a follow-up phase women who tested positive in any test at baseline will be monitored over a period of 10 years
Study close out visit In addition approximately 5 years after baseline ThinPrep LBC cervical samples will be collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value NPV and HPV related disease after a 5 year period Women who tested positive in any test will undergo colposcopy
Within a follow-up phase women who tested positive in any test at baseline will be monitored over a period of 10 years
Study close out visit In addition approximately 5 years after baseline ThinPrep LBC cervical samples will be collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value NPV and HPV related disease after a 5 year period Women who tested positive in any test will undergo colposcopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None