Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens
- Conditions
- Human Papilloma Virus Infection
- Interventions
- Other: Thinprep® LBCOther: APTIMA® HPV AssayOther: HR HC2® HPV DNAOther: Colposcopy
- Registration Number
- NCT02634190
- Lead Sponsor
- Hologic Deutschland GmbH
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women tested positive Thinprep® LBC 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 Women tested positive 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 Triple negative women Thinprep® LBC 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 tested positive HR HC2® HPV DNA 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 Triple negative women Colposcopy 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 Triple negative women APTIMA® HPV Assay 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 Triple negative women HR HC2® HPV DNA 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 tested positive Colposcopy 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
- Primary Outcome Measures
Name Time Method Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test Baseline
- Secondary Outcome Measures
Name Time Method Prevalence of HR HPV infection by age with HC2® and APTIMA Baseline, 5 years Specificity of LBC, HC2® and APTIMA® tests Baseline, 5 years Sensitivity of LBC, HC2® and APTIMA® tests Baseline, 5 years Relative risk of cervical disease for positive tested women Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years 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.
Cumulative risk of cervical diseases for positive tested women at 5 years Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years Cross sectional association between HR HPV infection (HC2® and APTIMA) and LBC diagnosis Baseline, 5 years Linear regression models will be used for determination of cross sectional associations between HR HPV Infection and LBC diagnosis.
Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests Baseline Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests Baseline