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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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. |
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Inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Van Damme | Centre for the Evaluation of Vaccination | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Antwerp - Centre for the Evaluation of Vaccination | Wilrijk | Antwerp | 2610 | Belgium |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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First-void urine samples, self collected vaginal swabs and physician collected cervical brush samples
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 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |