Clinical trial NCT02714127: Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Human Papillomavirus
Biomarker
Self-sampling
First-void urine
Cervicovaginal fluid
Colposcopy
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: University Hospital, Antwerp
First posted: 2016-03-21
Enrollment: 128
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort of women involves 100 women, diagnosed with an abnormal smear and/or high risk HPV infection (cytology results already available) requested for colposcopic examination. During this colposcopic examination, cervical samples are collected and send to the pathology laboratory. In addition, these women are asked to collect a first-void urine sample with the Colli-PeeTM device and fill in a questionnaire, prior to their colposcopy exam at the clinic (UZA), during which a cervicovaginal lavage fluid sample will be collected as well.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of cervical cancer biomarkers in first-void urine
timeFrame: Within 6 months after study completion
Secondary outcomes:
measure: Preference of women for self-sampling methods
timeFrame: Within 6 months after study completion
measure: Concentration of cervical cancer biomarkers in VagLav samples versus first-void urine
timeFrame: Within 6 months after study completion
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Wiebren Tjalma
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre Van Damme, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References: