Clinical trial · Observational

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

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

NCT02634190CI-TRIAL-00074527completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Human Papilloma Virus Infection	—	UNRESOLVED	—

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
APTIMA® HPV Assay	Other	—	UNRESOLVED
Colposcopy	Other	—	UNRESOLVED
HR HC2® HPV DNA	Other	—	UNRESOLVED
Thinprep® LBC	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Triple negative women
description
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
interventionNames
1. Other: Thinprep® LBC
2. Other: APTIMA® HPV Assay
3. Other: HR HC2® HPV DNA
4. Other: Colposcopy
label
Women tested positive
description
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
interventionNames
1. Other: Thinprep® LBC
2. Other: APTIMA® HPV Assay
3. Other: HR HC2® HPV DNA
4. Other: Colposcopy

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 30 Years
Maximum age: 60 Years

Show eligibility criteria text

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

References

Publications (2)

RESULTIftner 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. PMID 26019212
RESULTIftner 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. PMID 30355760