Detection of Biomarkers in First-void Urine Samples for Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Pierre Van Damme
Principal Investigator
Universiteit Antwerpen
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
Time Frame: Within 6 months after study completion
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.
Secondary Outcomes
- Validate the performance of additional biomarkers.(Within 6 months after study completion)
- 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)
- Preference of women for self-sampling methods.(Within 6 months after study completion)