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

February 26, 2024 updated by: Hologic Deutschland GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 58 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Women 30 years of age or older coming for routine cervical screening are enrolled in gynaecological practices.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Thinprep® LBC
liquid based cytology
Other: APTIMA® HPV Assay
in vitro diagnostic test
Other: HR HC2® HPV DNA
in vitro diagnostic test
Other: Colposcopy
Colposcopy
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
Other: Thinprep® LBC
liquid based cytology
Other: APTIMA® HPV Assay
in vitro diagnostic test
Other: HR HC2® HPV DNA
in vitro diagnostic test
Other: Colposcopy
Colposcopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall high risk (HR) HPV prevalence with HR HC2® HPV and APTIMA® test
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of LBC, HC2® and APTIMA® tests
Time Frame: Baseline, 5 years
Baseline, 5 years
Specificity of LBC, HC2® and APTIMA® tests
Time Frame: Baseline, 5 years
Baseline, 5 years
Positive Predictive Value (PPV) of LBC, HC2® and APTIMA® tests
Time Frame: Baseline
Baseline
Negative Predictive Value (NPV) of LBC, HC2® and APTIMA® tests
Time Frame: Baseline
Baseline
Prevalence of HR HPV infection by age with HC2® and APTIMA
Time Frame: Baseline, 5 years
Baseline, 5 years
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.
Baseline, 5 years
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.
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
Time Frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Baseline, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years

Other Outcome Measures

Outcome Measure
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
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic Deutschland GmbH

Collaborators

University Hospital Tuebingen

Investigators

  • Principal Investigator: Thomas Iftner, Prof., University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimated)

December 17, 2015

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aptima Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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