Status:
COMPLETED
CASUS: Improved and Quality Assured Collection of First-void Urine
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Novosanis NV
Conditions:
Cervical Cancer
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18+ years
Phase:
NA
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 o...
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 contr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04480866
Start Date
July 30 2019
End Date
November 27 2019
Last Update
July 21 2020
Active Locations (1)
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1
Centre for the Evaluation of Vaccination (CEV) - Vaccine & Infectious Disease Institute (VAXINFECTIO) - University of Antwerp
Wilrijk, Antwerpen, Belgium, 2610