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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple negative women | 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 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thinprep® LBC | Other | liquid based cytology |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of longitudinal negative predictive value of HPV infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period | 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. | 5 years |
Inclusion criteria:
Exclusion criteria:
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Women 30 years of age or older coming for routine cervical screening are enrolled in gynaecological practices.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Iftner, Prof. | University Hospital Tuebingen | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26019212 | Result | Iftner T, Becker S, Neis KJ, Castanon A, Iftner A, Holz B, Staebler A, Henes M, Rall K, Haedicke J, von Weyhern CH, Clad A, Brucker S, Sasieni P. Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany. J Clin Microbiol. 2015 Aug;53(8):2509-16. doi: 10.1128/JCM.01013-15. Epub 2015 May 27. | |
| 30355760 |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003127 | Colposcopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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liquid based cytology LBC Specimens (ThinPrep® Pap Test)
| APTIMA® HPV Assay |
| Other |
in vitro diagnostic test |
|
| HR HC2® HPV DNA | Other | in vitro diagnostic test |
|
| Colposcopy | Other | Colposcopy |
|
| Baseline |
| Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests | Baseline |
| 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 | Linear regression models will be used for determination of cross sectional associations between HR HPV Infection and LBC diagnosis. | 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. | 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 | Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years |
| Cumulative risk of Human Papilloma Virus (HPV) infection (HR HPV HC2® test or APTIMA® HPV or LBC) 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. |
| 5 years |
| Result |
| Iftner T, Neis KJ, Castanon A, Landy R, Holz B, Woll-Herrmann A, Iftner A, Staebler A, Wallwiener D, Hann von Weyhern C, Neis F, Haedicke-Jarboui J, Martus P, Brucker S, Henes M, Sasieni P. Longitudinal Clinical Performance of the RNA-Based Aptima Human Papillomavirus (AHPV) Assay in Comparison to the DNA-Based Hybrid Capture 2 HPV Test in Two Consecutive Screening Rounds with a 6-Year Interval in Germany. J Clin Microbiol. 2019 Jan 2;57(1):e01177-18. doi: 10.1128/JCM.01177-18. Print 2019 Jan. |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |