First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)

Cervical Cancer Clinical Trial

Official title:

Detection of Biomarkers in First-void Urine Samples for Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03542513
• Other study ID #: B300201732818
• Status: Active, not recruiting
• Start date: October 30, 2017
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Neoplasms
• Uterine Cervical Dysplasia

Intervention

Device:
• Colli-Pee
Urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium).
• Qvintip
Vaginal self-samples will be collected with the Qvintip (Aprovix AB, Uppsala, Sweden).

Locations

Country	Name	City	State
Belgium	University of Antwerp - Centre for the Evaluation of Vaccination	Wilrijk	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	Within 6 months after study completion
Secondary	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
Secondary	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