Clinical trial · Interventional
CASUS: Improved and Quality Assured Collection of First-void Urine
Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Improved and Quality Assured Collection of First-void Urine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| HPV-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
| Human Papilloma Virus | — | UNRESOLVED | — |
| Urine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colli-Pee® (FV5000 and Small Volumes) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- First-void urine collection
- description
- Women self-collect three first-void urine samples (random order) at home.
- interventionNames
- Device: Colli-Pee® (FV5000 and Small Volumes)
Primary outcomes (3)
- measure
- Human DNA (GAPDH)
- timeFrame
- Evaluation/testing when all samples are collected [1 year]
- description
- Comparison of human DNA (GAPDH) concentrations \[cycle threshold values\] between first-void urine volumes (4, 10, 20 mL) and extraction methods measured by quantitative PCR (qPCR).
- measure
- Internal control DNA (IC DNA)
- timeFrame
- Evaluation/testing when all samples are collected [1 year]
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available