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

Hologic Deutschland GmbH10,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Human Papilloma Virus Infection

Interventions

Thinprep® LBCOTHER

liquid based cytology

APTIMA® HPV AssayOTHER

in vitro diagnostic test

HR HC2® HPV DNAOTHER

in vitro diagnostic test

Colposcopy

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Women aged 30 - 60 years * Women attending gynaecological practices for routine screening * Women who gave informed consent to participation in the study Exclusion criteria: * Women with hysterectomy or known destructive therapy to the cervix * Women who are pregnant * Women with an abnormal cytology result during the previous 6 months * Women with known HIV infection or history of transplants * Women vaccinated against HPV * Women participating in another research protocol

Outcomes

Primary Outcomes

Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test

Time frame: Baseline

Secondary Outcomes

Sensitivity of LBC, HC2® and APTIMA® tests

Time frame: Baseline, 5 years

Specificity of LBC, HC2® and APTIMA® tests

Time frame: Baseline, 5 years

Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests

Time frame: Baseline

Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests

Time frame: Baseline

Prevalence of HR HPV infection by age with HC2® and APTIMA

Time frame: Baseline, 5 years

Cross sectional association between HR HPV infection (HC2® and APTIMA) and LBC diagnosis

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

Time frame: Baseline, 5 years

Relative risk of cervical disease for positive tested women

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.

Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years

Cumulative risk of cervical diseases for positive tested women at 5 years

Data from ClinicalTrials.gov

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