Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens
NCT ID: NCT02634190
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10000 participants
OBSERVATIONAL
2009-06-30
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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
Thinprep® LBC
liquid based cytology
APTIMA® HPV Assay
in vitro diagnostic test
HR HC2® HPV DNA
in vitro diagnostic test
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
Thinprep® LBC
liquid based cytology
APTIMA® HPV Assay
in vitro diagnostic test
HR HC2® HPV DNA
in vitro diagnostic test
Colposcopy
Colposcopy
Interventions
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Thinprep® LBC
liquid based cytology
APTIMA® HPV Assay
in vitro diagnostic test
HR HC2® HPV DNA
in vitro diagnostic test
Colposcopy
Colposcopy
Eligibility Criteria
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Inclusion Criteria
* Women attending gynaecological practices for routine screening
* Women who gave informed consent to participation in the study
Exclusion Criteria
* 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
30 Years
60 Years
FEMALE
Yes
Sponsors
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University Hospital Tuebingen
OTHER
Hologic Deutschland GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Iftner, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tuebingen
References
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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.
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.
Other Identifiers
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Aptima Study
Identifier Type: -
Identifier Source: org_study_id
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