NCT02634190

Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens

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
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (actual)
• Sponsor: Hologic Deutschland GmbH · Industry
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To assess and compare the performance of the HR HPV HC2® test (Qiagen/Digene) 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, 10.000 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.

Conditions

• Human Papilloma Virus Infection

Interventions

Type	Name	Description
OTHER	Thinprep® LBC	liquid based cytology
OTHER	APTIMA® HPV Assay	in vitro diagnostic test
OTHER	HR HC2® HPV DNA	in vitro diagnostic test
OTHER	Colposcopy	Colposcopy

Timeline

• Start date: 2009-06-01
• Primary completion: 2021-06-01
• Completion: 2021-12-01
• First posted: 2015-12-17
• Last updated: 2024-02-28