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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Colli-Pee
* Device: Qvintip


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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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. | 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. | 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. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus, Biomarker, Self-sampling, First-void urine, Cervical Intraepithelial Neoplasia, LLETZ