Clinical trial NCT03542513: First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
Official title: Detection of Biomarkers in First-void Urine Samples for Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Human Papillomavirus
Biomarker
Self-sampling
First-void urine
Cervical Intraepithelial Neoplasia
LLETZ
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2018-05-31
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
timeFrame: Within 6 months after study completion
Secondary outcomes:
measure: hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital.
timeFrame: Within 6 months after study completion
measure: Effect of treatment on HPV DNA presence.
timeFrame: Within 6 months after study completion
measure: Validate the performance of additional biomarkers.
timeFrame: Within 6 months after study completion
measure: Preference of women for self-sampling methods.
timeFrame: Within 6 months after study completion
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: University of Antwerp - Centre for the Evaluation of Vaccination
state: Antwerp
Study officials:
affiliation: Centre for the Evaluation of Vaccination
name: Pierre Van Damme
role: PRINCIPAL_INVESTIGATOR
References: