Brief Title
CASUS: Validation for Detection of Precursor Lesions
Official Title
Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Validation for Detection of Precursor Lesions
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 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 University Medical
Center, The Netherlands) on first-void urine (Colli-Pee Small Volumes (10 mL) device,
Novosanis, Belgium) of HPV positive women for detection of clinically relevant precursor
lesions by sampling a cohort of women referred for colposcopy. The number of women in this
cohort will allow us to clinically validate the use of the HPV-Risk/qMSP assay in DNA
extracts of first-void samples after optimization of sample volume, internal process control,
and DNA extraction method (Centre for the Evaluation of Vaccination, University of Antwerp,
Belgium).
Study Type
Interventional
Primary Outcome
HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) measured using the HPV-risk assay (Self-Screen BV).
Secondary Outcome
Human DNA (GAPDH)
Condition
Cervical Cancer
Intervention
Colli-Pee Small Volumes (10 mL) device
Study Arms / Comparison Groups
Sample collection
Description: Women will self-collect two first-void urine samples at home, the day prior to colposcopy. During the colposcopy visit, the clinician will collect an additional cervical smear. Colposcopy and histology results (when available) will be used as reference test.
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
332
Start Date
August 20, 2020
Completion Date
February 28, 2022
Primary Completion Date
October 20, 2021
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender
Female
Ages
25 Years - 64 Years
Accepts Healthy Volunteers
No
Contacts
Pierre Van Damme, MD, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT04530201
Organization ID
BE3002020000101
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
June 2022