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

June 10, 2025 updated by: Pierre Van Damme, Universiteit Antwerpen

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

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).

Study Overview

Status

Completed

Conditions

Cervical Cancer

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- Antwerp
  - Wilrijk, Antwerp, Belgium, 2610
    - University of Antwerp - Centre for the Evaluation of Vaccination

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The cohort involves 100 women, diagnosed with histologically confirmed high grade CIN lesions requested for LLETZ treatment. Before this treatment an extra cervical sample is collected by the clinician. In addition, these women are asked to collect first-void urine samples with the Colli-Pee device, vaginal samples with the Qvintip device and to fill in a questionnaire.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens. Time Frame: Within 6 months after study completion	Concordance hrHPV DNA status of self-collected first-void urine and vaginal samples from women treated for high-grade cervical lesions to that of physician sampled cervical specimens.	Within 6 months after study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital. Time Frame: Within 6 months after study completion	Concordance hrHPV DNA status of self-collected first-void urine and vaginal fluid samples at home to self-collected samples at the hospital.	Within 6 months after study completion
Effect of treatment on HPV DNA presence. Time Frame: Within 6 months after study completion	Evaluate the effect of treatment on HPV DNA presence by the use of self-collected first-void urine and vaginal self-sampling for HPV DNA detection.	Within 6 months after study completion
Validate the performance of additional biomarkers. Time Frame: Within 6 months after study completion	Validate the performance of additional biomarkers (mRNA, genotyping, DNA methylation markers, viral load) for further staging of hrHPV infections.	Within 6 months after study completion
Preference of women for self-sampling methods. Time Frame: Within 6 months after study completion	Gather information about the preference of women for first-void urine sample collection compared vaginal self-sampling methods, and a clinician collected sample (smear).	Within 6 months after study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

University Hospital, Antwerp

Investigators

Principal Investigator: Pierre Van Damme, Centre for the Evaluation of Vaccination

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

December 12, 2022

Study Completion (Actual)

September 25, 2024

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria