Non-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

Non-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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027908

Enrollment

360

Registered

2022-01-20

Start date

2021-12-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C01 C09

Interventions

Group 1: All patients included in the study will have blood samples taken during routine treatment and follow-up appointments (6 visits over 12 months), which will be analysed for HPV16 antibodies in

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Investigation of the correlation between the antibody titre measured at the start of therapy and the observed treatment success (prognostic value).	—

Countries

Germany

Contacts

Public ContactMarkus Hoffmann

Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie der Christian-Albrechts-Universität zuKiel

Markus.hoffmann@uksh.de04131 500 21710

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026