Cervical Cancer
Conditions
Keywords
Human Papillomavirus, Biomarker, Self-sampling, First-void urine, Cervical Intraepithelial Neoplasia, LLETZ
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.
Interventions
Sponsors
University Hospital, Antwerp
Universiteit Antwerpen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens. | 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
| Measure | Time frame | Description |
|---|---|---|
| hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital. | Within 6 months after study completion | Concordance hrHPV DNA status of self-collected first-void urine and vaginal fluid samples at home to self-collected samples at the hospital. |
| Effect of treatment on HPV DNA presence. | Within 6 months after study completion | 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. |
| Validate the performance of additional biomarkers. | Within 6 months after study completion | Validate the performance of additional biomarkers (mRNA, genotyping, DNA methylation markers, viral load) for further staging of hrHPV infections. |
| Preference of women for self-sampling methods. | Within 6 months after study completion | Gather information about the preference of women for first-void urine sample collection compared vaginal self-sampling methods, and a clinician collected sample (smear). |
Countries
Belgium
Outcome results
None listed