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

Human Papilloma Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634190
• Other study ID #: Aptima Study
• Status: Completed
• Start date: June 2009
• Est. completion date: December 2021

Study information

• Verified date: February 2024
• Source: Hologic Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections

Intervention

Other:
• Thinprep® LBC
liquid based cytology
• APTIMA® HPV Assay
in vitro diagnostic test
• HR HC2® HPV DNA
in vitro diagnostic test
• Colposcopy
Colposcopy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hologic Deutschland GmbH	University Hospital Tuebingen

References & Publications (2)

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 Cap — View 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 P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test		Baseline
Secondary	Sensitivity of LBC, HC2® and APTIMA® tests		Baseline, 5 years
Secondary	Specificity of LBC, HC2® and APTIMA® tests		Baseline, 5 years
Secondary	Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests		Baseline
Secondary	Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests		Baseline
Secondary	Prevalence of HR HPV infection by age with HC2® and APTIMA		Baseline, 5 years
Secondary	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
Secondary	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
Secondary	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