Clinical trial NCT02634190: Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papilloma Virus Infection
Keywords: Cervical cancer screening
High risk Human Papillomavirus
Aptima HPV Assay
Lead sponsor: Hologic Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Tuebingen
First posted: 2015-12-17
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Women 30 years of age or older coming for routine cervical screening are enrolled in gynaecological practices.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test
timeFrame: Baseline
Secondary outcomes:
measure: Sensitivity of LBC, HC2® and APTIMA® tests
timeFrame: Baseline, 5 years
measure: Specificity of LBC, HC2® and APTIMA® tests
timeFrame: Baseline, 5 years
measure: Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests
timeFrame: Baseline
measure: Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests
timeFrame: Baseline
measure: Prevalence of HR HPV infection by age with HC2® and APTIMA
timeFrame: Baseline, 5 years
measure: Cross sectional association between HR HPV infection (HC2® and APTIMA) and LBC diagnosis
timeFrame: Baseline, 5 years
measure: Relative risk of cervical disease for positive tested women
timeFrame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
measure: Cumulative risk of cervical diseases for positive tested women at 5 years
timeFrame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Other outcomes:
measure: Determination of longitudinal negative predictive value of HPV infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period
timeFrame: 5 years
measure: Cumulative risk of Human Papilloma Virus (HPV) infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period
timeFrame: 5 years
Locations:
Study officials:
affiliation: University Hospital Tuebingen
name: Thomas Iftner, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.