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Completed

NCT Number: NCT03542513

First-void Urine Samples for the 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).

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Antwerp - Centre for the Evaluation of Vaccination

Wilrijk, Antwerp, 2610, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colli-Pee

Device

Urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium).

Qvintip

Device

Vaginal self-samples will be collected with the Qvintip (Aprovix AB, Uppsala, Sweden).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
May 31, 2018
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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