CompletedNot Applicable

First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)

Belgium65 participantsStarted 2017-10-30

Plain-language summary

The aim of this study is to analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (CIN).

Who can participate

Age range18 Years – 64 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female (18 years and older) * Scheduled for LLETZ treatment of diagnosed, histologically confirmed high grade CIN lesions * Giving informed consent to the research team (CEV) to contact his/her GP and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy. * Not participating in another clinical study where a drug or biological is administered. * Able to understand the information brochure/what the study is about.

What they're measuring

hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.

Timeframe: Within 6 months after study completion

Trial details

NCT IDNCT03542513

SponsorUniversiteit Antwerpen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-12

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