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

 -  Female

 -  25-64 year old

 -  Women scheduled for a colposcopy exam due to abnormal cytology result according to the
 Bethesda classification 2001 (NILM, AGC (Atypical Glandular Cells), ASC-US (Atypical
 Squamous Cells of Undetermined Significance), ASC-H (Atypical Squamous Cells - cannot
 exclude HSIL), LSIL (Low-grade Squamous Intraepithelial Lesion), HSIL (High-grade
 Squamous Intraepithelial Lesion), invasive carcinoma), and/or positive for hrHPV
 infection. NILM (Negative for Intraepithelial Lesion or Malignancy) are only included
 when positive for hrHPV infection.

 -  Signing informed consent form (ICF).

 -  Giving consent to the research team (CEV) to contact his/her general practioner and/or
 gynaecologist to access details of the participants HPV vaccination (schedule) and
 results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in
 ICF).

 Exclusion Criteria:

 -  Participating in another clinical study at the same time of participating in this
 study.

 -  Not able to understand the information brochure/what the study is about.

 -  Anything in the opinion of the investigator that would prevent volunteers from
 completing the study or put the volunteer at risk.