Observational study on the use of HPV16-L1 antibody tests in the context of HPV-cancer screening in HIV-positive and HIV-negative patients attending the proctology clinic

Abviris Deutschland GmbH0 个研究点目标入组 400 人开始时间: 2022年7月8日最近更新: 2024年8月19日

适应症

试验速览

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•1. age: 18 to 64 years
•2. willingness and ability to provide informed consent
•3. signed declaration of consent
•4. participation in a standardised examination (high-resolution anoscopy) as part of the proctological consultation
•5. wish to undergo a Prevo-Check® test for HPV16 L1 antibodies as part of the consultation
•6. willingness for telephone contact 6 months after participation in the study

•1. logistical or medical circumstances that would put the patient at increased risk from the study. The study doctor will make the decision based on the patient's medical history and/or clinical picture or laboratory results.
•2. pregnancy
•3. patients who have been vaccinated against HPV (exclusion criterion for Prevo-Check®).
•4. participation in a concurrent study other than an observational study
•5. current or previously diagnosed HPV-related carcinoma (e.g. oropharyngeal, tonsillar, cervical or anal carcinoma) for which therapy has been started or completed
•6. immunosuppressive therapy (chemotherapy within the last 6 months, oral steroids >5mg prednisolone equivalent within the last 4 weeks, other immunosuppressive drugs within the last 6 months).

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