Cervical Cancer Clinical Trial
Official title:
Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine: the BM-SOP Study
The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and biomarker assays to analyze a panel of biomarkers in first-void urine for improved diagnosis of cervical (pre)cancer lesions.
In total 100 women will be included in this trial, women diagnosed with abnormal cytology
results and/or high risk HPV (Human Papillomavirus) infection scheduled for a colposcopy
exam. These women are asked to collect a first-void urine sample with the Colli-PeeTM
device, prior to their colposcopy exam at the clinic. The collected urine samples will be
used for the development and optimisation of robust analytical protocols for first-void
urine sample preparation and biomarker assays.
During colposcopy, the cervix will be visually inspected, whether or not combined with a
biopsy for histological confirmation. Colposcopy is a procedure to identify abnormalities by
using a colposcope that gives an illuminated, magnified view of the cervical region. It
often includes rinsing the cervicovaginal region with 50 ml acetic acid (5%). Here, this
fluid will be collected and serve as the intermediate step between biomarkers in
cervicovaginal secretions and urine.
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