Brief Title
CASUS: Improved and Quality Assured Collection of First-void Urine
Official Title
Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Improved and Quality Assured Collection of First-void Urine
Brief Summary
The goal of the overall CASUS project is to develop the first fully molecular integrated
cervical cancer screening approach, based on first-void urine as an easily accessible and
non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS
approach will identify women with clinically relevant disease in need of treatment using only
a single sample that can be collected at home (one-step triage).
Detailed Description
CASUS work package 1 (WP1): To accommodate for the detection of biomarkers in first-void
urine, a next-generation first-void urine collection device is necessary, which includes
internal process control, novel collector tubes for collection of smaller urine volumes, and
integration of a non-toxic nucleic acid preservative.
Hereto, new generations of the Colli-Pee® (Novosanis) first-void urine collector allowing
collection of smaller volumes (Colli-Pee Small Volumes 4 and 10 mL) next to the 'standard'
Colli-Pee FV5000 (20 mL) first-void urine collector will be developed and validated. The
optimal urine volume needed for detection of host and viral biomarkers, as well as
optimization of the nucleic acid preservative solution by introduction of a sample/extraction
validation control (non-human DNA internal control (DNA IC)) will be evaluated by measuring
the concentration of human DNA, HPV DNA, and the DNA IC in all first-void urine samples using
different DNA extraction protocols.
Study Type
Interventional
Primary Outcome
Human DNA (GAPDH)
Secondary Outcome
Human DNA (Beta-globin)
Condition
Cervical Cancer
Intervention
Colli-Pee® (FV5000 and Small Volumes)
Study Arms / Comparison Groups
First-void urine collection
Description: Women self-collect three first-void urine samples (random order) at home.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
25
Start Date
July 30, 2019
Completion Date
November 27, 2019
Primary Completion Date
November 25, 2019
Eligibility Criteria
Inclusion Criteria:
- Female
- 18 years and older
- Women with a high-risk HPV positive test result within six months prior to study
enrolment.
- Giving informed consent to the research team to contact his/her general practitioner
and/or gynaecologist to access details of the participants HPV test results and
cervical screening history.
- Able to understand the information brochure/what the study is about.
Exclusion Criteria:
- Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions
within the previous six months prior to study enrolment.
- Participating in another interventional clinical study (where e.g. a medical device,
drug, or vaccine is evaluated) at the same time of participating in this study.
Participation in another observational or low-interventional clinical study at the
same time is allowed.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pierre Van Damme, MD, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT04480866
Organization ID
B300201940120
Responsible Party
Principal Investigator
Study Sponsor
Universiteit Antwerpen
Collaborators
Amsterdam UMC, location VUmc
Study Sponsor
Pierre Van Damme, MD, PhD, Principal Investigator, Universiteit Antwerpen
Verification Date
July 2020