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

NCT03542513 | Completed FDA Device

• 1 other identifier: B300201732818
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cervical Cancer

Keywords

Human Papillomavirus; Biomarker; Self-sampling; First-void urine; Cervical Intraepithelial Neoplasia; LLETZ

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

• hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital.

  Within 6 months after study completion

• Effect of treatment on HPV DNA presence.

  Within 6 months after study completion

• Validate the performance of additional biomarkers.

  Within 6 months after study completion

• Preference of women for self-sampling methods.

  Within 6 months after study completion

Interventions

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).

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

University of Antwerp - Centre for the Evaluation of Vaccination

Wilrijk, Antwerp, 2610, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

First-void urine samples, self collected vaginal swabs and physician collected cervical brush samples

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre Van Damme

  Centre for the Evaluation of Vaccination

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: May 31, 2018
• Study Start: October 30, 2017
• Primary Completion: December 12, 2022
• Study Completion: September 25, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)