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NCT Number: NCT02634190

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

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.

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Key information

Conditions

Human Papilloma Virus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thinprep® LBC

Other

liquid based cytology

APTIMA® HPV Assay

Other

in vitro diagnostic test

HR HC2® HPV DNA

Other

in vitro diagnostic test

Colposcopy

Other

Colposcopy

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

  1. Sensitivity of LBC, HC2® and APTIMA® tests

    Time frame: Baseline, 5 years

  2. Specificity of LBC, HC2® and APTIMA® tests

    Time frame: Baseline, 5 years

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline, 5 years

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

    Time frame: Baseline, 5 years

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

  7. Relative risk of cervical disease for positive tested women

    Time frame: 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.

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

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

Other outcomes

  1. Determination of longitudinal negative predictive value of HPV infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period

    Time frame: 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.

  2. Cumulative risk of Human Papilloma Virus (HPV) infection (HR HPV HC2® test or APTIMA® HPV or LBC) after a 5 year period

    Time frame: 5 years

    In triple negative study participants at baseline the cumulative risk of HPV infection will be determined after a 5 year period.

Sponsors and collaborators

Lead sponsor

Hologic Deutschland GmbH

Industry

Collaborators

  • University Hospital Tuebingen

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2015
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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