CompletedNot Applicable

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

10,000 participantsStarted 2009-06

Plain-language 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.

Who can participate

Age range

30 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline

Trial details

NCT IDNCT02634190

SponsorHologic Deutschland GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06

View on ClinicalTrials.gov More Human Papilloma Virus Infection trials