Cervical Cancer
Conditions
Keywords
Human Papillomavirus, Biomarker, Self-sampling, First-void urine, Cervicovaginal fluid, Colposcopy
Brief 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.
Detailed description
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.
Interventions
One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).
OTHERCervicovaginal lavage fluid collection
During colposcopy, the cervicovaginal region is rinsed for 2 minutes with 50 ml acetic acid (5%). This fluid is not discarded like it is done usually, but the remaining lavage fluid (5% acetic acid containing cervicovaginal fluid) will be collected.
Sponsors
Research Foundation Flanders
University Hospital, Antwerp
Universiteit Antwerpen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of cervical cancer biomarkers in first-void urine | Within 6 months after study completion | To detect candidate biomarkers (originally identified in cervical cells, tissue biopsies, and cervicovaginal fluid (CVF); HPV DNA type(s), viral load (copies/cel), proteins, (m)RNA, methylated (HPV and human) DNA, immunoglobulins; in first-void urine samples from 100 women scheduled for colposcopy due to abnormal cytology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preference of women for self-sampling methods | Within 6 months after study completion | Gather information about the preference of women for first-void urine sample collection compared to the currently available self-sampling methods, and a clinician collected sample (smear). |
| Concentration of cervical cancer biomarkers in VagLav samples versus first-void urine | Within 6 months after study completion | To compare the presence of candidate biomarkers (originally identified in cervical cells, tissue biopsies, and cervicovaginal fluid (CVF); HPV DNA type(s), viral load (copies/cel), proteins, (m)RNA, methylated (HPV and human) DNA, immunoglobulins; in paired first-void urine and VagLav samples from 100 women scheduled for colposcopy due to abnormal cytology. |
Countries
Belgium
Outcome results
None listed