Non-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

Non-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 - PRECISE I

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027245

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: Qualitative (Prevo-Check) and quantitative (PT Monitor) immunoassays are used to measure HPV16 L1 antibodies in patients with suspected oropharyngeal carcinoma. The blood sample is collected

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
The positive percent agreement (PPA) of the antibody tests in relation to HPV16-positive tumours, as classified by mRNA detection in tumor tissue at the time of diagnosis, determined separately for Prevo-Check® and PT Monitor®. It shall be shown that the percentage positive agreement is significantly greater than 80%.	—

Secondary

Measure	Time frame
The negative percent agreement (NPA) of the antibody tests in relation to HPV16-positive tumours, as classified by mRNA at the time of diagnosis, determined separately for Prevo-Check® and PT Monitor®. Positive and negative percent agreement with the mRNA detection is also calculated for the other methods (HPV DNA detection by PCR and histopathological staining for p16INK4a) and then compared with the results of Prevo-Check® and PT Monitor®.	—

Measure

Time frame

The negative percent agreement (NPA) of the antibody tests in relation to HPV16-positive tumours, as classified by mRNA at the time of diagnosis, determined separately for Prevo-Check® and PT Monitor®. Positive and negative percent agreement with the mRNA detection is also calculated for the other methods (HPV DNA detection by PCR and histopathological staining for p16INK4a) and then compared with the results of Prevo-Check® and PT Monitor®.

—

Countries

Germany

Contacts

Public ContactMarkus Hoffmann

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

Markus.Hoffmann@uksh.de0431 500 21710

Outcome results

None listed

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