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

NCT02634190 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Human Papilloma Virus Infection

Interventions

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

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • Hologic Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Thomas Iftner, Prof. · University Hospital Tuebingen

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2021-06-30
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02634190 on ClinicalTrials.gov