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.
Study Type
OBSERVATIONAL
Enrollment
65
University of Antwerp - Centre for the Evaluation of Vaccination
Wilrijk, Antwerp, Belgium
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.
Time frame: Within 6 months after study completion
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Within 6 months after study completion
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