on-interventional clinical performance study on the use of HPV16 L1 antibody assays Prevo-Check and PT Monitor in the aid of the diagnosis of HPV16-induced tumors in patients with oropharyngeal cancer
- Conditions
- C01C09Malignant neoplasm of base of tongueMalignant neoplasm of tonsil
- Registration Number
- DRKS00027245
- Lead Sponsor
- Abviris Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 360
1. =18 years
2. willingness and ability to provide informed consent.
3. signed informed consent form
4. Suspected diagnosis: oropharyngeal carcinoma (ICD-10 C01 (base of tongue) or C09 (tonsil)).
5. willingness to participate in the study PRECISE ENT II
1. a surgical or medical circumstance that would place the patient at increased risk from the study. The investigator will make the decision based on the patient's medical history and/or clinical picture or laboratory results.
2. patients who have been vaccinated against HPV or will be vaccinated in the course of the study
3. therapy for oropharyngeal carcinoma started before inclusion in the study
4. participation in any other clinical trial other than observational studies
5. known other current or previously diagnosed HPV-related carcinomas, e.g., cervical or anal carcinoma (as verbally informed by patient).
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method