on-interventional exploratory study on the measurement of HPV16 L1 antibodies with PT Monitor® as part of therapy monitoring in patients with HPV16-induced tumours in the oropharyngeal area - PRECISE II

Abviris Deutschland GmbH0 个研究点目标入组 360 人开始时间: 2022年1月20日最近更新: 2024年8月19日

试验速览

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•1. age > 18 years
•2. willingness and ability to give informed consent
•3. signed informed consent form
•4. consent to attend the required follow-up appointments
•5. diagnosis of squamous cell carcinoma of the oropharynx (OPSCC, ICD-10 C01 (base of tongue) or C09 (tonsil))
•6. participation in the PRECISE I study
•7. therapy for oropharyngeal carcinoma not yet started.

•1. logistical or medical circumstances that would place the patient at increased risk from the study. The investigator will make the decision based on the patient's medical history or/and clinical picture or laboratory values.
•2. lack of willingness and ability to give informed consent
•3. patients who have been vaccinated against HPV or will be vaccinated against HPV during this study,
•4. patients diagnosed with HPV16 tumour who have already started treatment.
•5. participation in a concurrent study other than an observational study.
•6. known other current or previously diagnosed HPV-related neoplasia, e.g. anal carcinoma, cervical dysplasia (according to oral information provided by the patient).

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