NCT03542513

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In total 100 women, diagnosed with CIN2/3 and scheduled for LLETZ (Large Loop Excision of the Transformation Zone), will be included in this trial. These women are asked to collect two FV urine samples with the Colli-Pee device (Novosanis, Wijnegem, Belgium) prior to their treatment (one at home and one at the hospital) and at five additional time points post treatment (1-3-6-12-24 months) at home. In addition, five self-collected vaginal swabs will be taken, two before treatment (1 at home and 1 at the hospital) and three (6-12-24 months) after treatment at home. Qvintip devices are used for vaginal self-sampling. During follow-up visits cervical samples and optional biopsies are collected by the physician and respectively send to the UZA anatomic pathology unit to determine the patient's HPV status, cytology and histology. For the study, one extra cervical sample will be taken by the physician just before treatment, that is not part of the normal standard procedure.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DEVICE	Colli-Pee	Urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium).
DEVICE	Qvintip	Vaginal self-samples will be collected with the Qvintip (Aprovix AB, Uppsala, Sweden).

Timeline

• Start date: 2017-10-30
• Primary completion: 2022-12-12
• Completion: 2024-09-25
• First posted: 2018-05-31
• Last updated: 2025-06-13

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study