Status:
COMPLETED
CASUS: Validation for Detection of Precursor Lesions
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Novosanis NV
Conditions:
Cervical Cancer
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
25-64 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 4 (WP4): The main aim of this study is to validate the HPV-Risk assay (Self-screen, The Netherlands) followed by multiplex methylation specific quantitative PCR (qMSP, VU Universit...
Eligibility Criteria
Inclusion
- Female
- 25 years until 64 years old
- Referred to colposcopy due to a single/multiple (probable) high-risk HPV infection and/or abnormal cervical squamous intraepithelial/glandular lesion.
- Gives informed consent to the research team at the clinical study site to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
- Is able to understand the information brochure/what the study is about.
Exclusion
- Women that underwent hysterectomy
- Pregnant women
- Treatment for cervical cancer in the last 6 months before participation in the study
- Participating in an 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 :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT04530201
Start Date
August 20 2020
End Date
February 28 2022
Last Update
June 15 2022
Active Locations (3)
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1
Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent)
Ghent, Oost-Vlaanderen, Belgium, 9000
2
Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen
Tienen, Vlaams-Brabant, Belgium, 3300
3
Gynécologie-obstétrique - CHU de Liège
Liège, Belgium, 4030