Observational study on the use of HPV16-L1 antibody tests in the context of HPV-cancer screening in HIV-positive and HIV-negative patients attending the proctology clinic

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029167

Enrollment

400

Registered

2022-07-08

Start date

2022-07-18

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

C21

Interventions

Group 1: Anal cancer screening and Prevo-Check rapid test as part of the routine examination of patients attending the proctology clinic

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. age: 18 to 64 years 2. willingness and ability to provide informed consent 3. signed declaration of consent 4. participation in a standardised examination (high-resolution anoscopy) as part of the proctological consultation 5. wish to undergo a Prevo-Check® test for HPV16 L1 antibodies as part of the consultation 6. willingness for telephone contact 6 months after participation in the study

Exclusion criteria

Exclusion criteria: 1. logistical or medical circumstances that would put the patient at increased risk from the study. The study doctor will make the decision based on the patient's medical history and/or clinical picture or laboratory results. 2. pregnancy 3. patients who have been vaccinated against HPV (exclusion criterion for Prevo-Check®). 4. participation in a concurrent study other than an observational study 5. current or previously diagnosed HPV-related carcinoma (e.g. oropharyngeal, tonsillar, cervical or anal carcinoma) for which therapy has been started or completed 6. immunosuppressive therapy (chemotherapy within the last 6 months, oral steroids >5mg prednisolone equivalent within the last 4 weeks, other immunosuppressive drugs within the last 6 months).

Design outcomes

Primary

Measure	Time frame
- Prevalence of Prevo-Check®-positive patients in patients attending proctology clinic - Diagnostic performance parameters (sensitivity, specificity, PPV, NPV) of Prevo-Check® regarding HPV16-associated anal neoplasia	—

Secondary

Measure	Time frame
- Quantitative testing of HPV16 antibodies using PT Monitor® and comparison of the optimal concentration cut-off for the detection of anal neoplasia in patients with and without HIV	—

Countries

Germany

Contacts

Public ContactAnja Potthoff

Interdisziplinäre Immunologische Ambulanz Zentrum für sexuelle Gesundheit und MedizinKlinik für Dermatologie, Venerologie und AllergologieRuhr-Universität Bochum

anja.potthoff@klinikum-bochum.de0234-5098921

Outcome results

None listed

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