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Disease Attributes

Women 30 years of age or older coming for routine cervical screening who tested triple negative at baseline with the interventions: Thinprep® LBC, HR HC2® HPV DNA and APTIMA® HPV Assay

Women who tested positive in any of the tests Thinprep® LBC, HR HC2® HPV DNA or APTIMA® HPV Assay will undergo colposcopy and be followed up over a ten year period and subjects who tested positive during the follow up assessment will be followed up over a 5 year period on a yearly basis

Thinprep® LBC

APTIMA® HPV Assay

HR HC2® HPV DNA

Colposcopy

Thomas Iftner, Prof.

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.

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.

liquid based cytology LBC Specimens (ThinPrep® Pap Test)

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

In triple negative study participants (HR HPV HC2® test and APTIMA® HPV and LBC) at baseline the longitudinal negative predictive value of HPV infections will be determined after a 5 year period.

In triple negative study participants at baseline the cumulative risk of HPV infection will be determined after a 5 year period.

Linear regression models will be used for determination of cross sectional associations between HR HPV Infection and LBC diagnosis.

Analysis of study results at baseline and follow-up visits. Calculation of relative risks of cervical disease for women who are positive for LBC, HC2® and/or APTIMA® test compared to those being negative for any of the three tests at the baseline visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens	NCT02634190	Human Papilloma...	Thinprep® LBC APTIMA® HPV Ass... HR HC2® HPV DNA Colposcopy	30 Years - 60 Years	Hologic Deutschland GmbH
Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens	NCT02634190	Human Papilloma...	Thinprep® LBC APTIMA® HPV Ass... HR HC2® HPV DNA Colposcopy	30 Years - 60 Years	Hologic Deutschland GmbH

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