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 sites360 target enrollmentJanuary 20, 2022

Overview

No summary available.

Registry

who.int

Start Date

January 20, 2022

End Date

TBD

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

•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).