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

Recruiting

Conditions: C01
C09
Malignant neoplasm of base of tongue
Malignant neoplasm of tonsil

Registration Number: DRKS00027908

Lead Sponsor: Abviris Deutschland GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 360

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observation of the percentage change in the amount of HPV16 L1 antibodies in serum relative to the individual baseline value at the start of therapy within a period of 48 weeks after the start of therapy and its correlation with the clinical findings.

Secondary Outcome Measures