Human Papilloma Virus Infection
Conditions
Keywords
Cervical cancer screening, High risk Human Papillomavirus, Aptima HPV Assay
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.
Interventions
OTHERThinprep® LBC
liquid based cytology
OTHERAPTIMA® HPV Assay
in vitro diagnostic test
OTHERHR HC2® HPV DNA
in vitro diagnostic test
OTHERColposcopy
Colposcopy
Sponsors
University Hospital Tuebingen
Hologic Deutschland GmbH
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of LBC, HC2® and APTIMA® tests | Baseline, 5 years | — |
| Specificity of LBC, HC2® and APTIMA® tests | Baseline, 5 years | — |
| Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests | Baseline | — |
| Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests | Baseline | — |
| 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 | — |
| Prevalence of HR HPV infection by age with HC2® and APTIMA | Baseline, 5 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determination of longitudinal negative predictive value of HPV infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period | 5 years | 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. |
| Cumulative risk of Human Papilloma Virus (HPV) infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period | 5 years | In triple negative study participants at baseline the cumulative risk of HPV infection will be determined after a 5 year period. |
Outcome results
None listed