Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium).

Colli-Pee

Vaginal self-samples will be collected with the Qvintip (Aprovix AB, Uppsala, Sweden).

Qvintip

Pierre Van Damme

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.

First-void urine samples, self collected vaginal swabs and physician collected cervical brush samples

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

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

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.

Concordance hrHPV DNA status of self-collected first-void urine and vaginal fluid samples at home to self-collected samples at the hospital.

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 (mRNA, genotyping, DNA methylation markers, viral load) for further staging of hrHPV infections.

Gather information about the preference of women for first-void urine sample collection compared vaginal self-sampling methods, and a clinician collected sample (smear).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)	NCT03542513	Cervical Cancer	Colli-Pee Qvintip	18 Years - 64 Years	Universiteit Antwerpen
First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)	NCT03542513	Cervical Cancer	Colli-Pee Qvintip	18 Years - 64 Years	Universiteit Antwerpen

Spots Global Cancer Trial Database for qvintip

Every month we try and update this database with for qvintip cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for qvintip

Every month we try and update this database with for qvintip cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for qvintip cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.