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Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)

2016-03-22 06:23:23 | BioPortfolio

Summary

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.

Description

In total 50 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Conditions

Cervical Cancer

Intervention

First-void urine collection, Cervicovaginal lavage fluid collection

Location

Wiebren Tjalma
Edegem
Antwerp
Belgium
2650

Status

Recruiting

Source

Universiteit Antwerpen

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-22T06:23:23-0400

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