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

Conditions: C21
Malignant neoplasm of anus and anal canal

Registration Number: DRKS00029167

Lead Sponsor: Abviris Deutschland GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 400

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

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).

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Prevalence of Prevo-Check®-positive patients in patients attending proctology clinic<br>- Diagnostic performance parameters (sensitivity, specificity, PPV, NPV) of Prevo-Check® regarding HPV16-associated anal neoplasia

Secondary Outcome Measures

Name	Time	Method
- 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