high risk HPV detection from urine and self-collected specimens as patient friendly alternative for physician taken smears

Recruiting

• Conditions: Cervical dysplasia / Cervical cancer; 10016417

• Registration Number: NL-OMON48967
• Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

HPV positive woman
18 years or older

Exclusion Criteria

Pregnant
Under 18 years of age

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For both the self-collected specimens and urine the most optimal combination of<br /><br>HPV DNA/RNA isolation and detection will be determined. Stability of HPV DNA<br /><br>and RNA on the Evalyn Brush will be investigated by comparing results on<br /><br>timepoints T=0 and T=4 days. For urine, the effect of adding preservationmedium<br /><br>on stability of HPV DNA and RNA will be investigated. Furthermore, urine will<br /><br>be analysed on different timepoints (T=0, 4 and 7 days) to analyse stability of<br /><br>HPV. All obtained results from the self-collected specimens and urine will be<br /><br>compared to the results of the physician taken smear (routine diagnostics,<br /><br>golden standard).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>