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NCT04530201: CASUS-WP4
CASUS: Validation for Detection of Precursor Lesions
NA trial testing Colli-Pee Small Volumes (10 mL) device in Cervical Cancer in 332 participants. Completed in 28 February 2022.
20 October 2021
Quick facts
| Lead sponsor | Universiteit Antwerpen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 332 |
| Start date | 20 August 2020 |
| Primary completion | 20 October 2021 |
| Estimated completion | 28 February 2022 |
| Sites | 3 locations across Belgium |
Drugs / interventions tested
- Colli-Pee Small Volumes (10 mL) device
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
- Cervical Intraepithelial Neoplasia — all drugs for Cervical Intraepithelial Neoplasia →
- Human Papilloma Virus — all drugs for Human Papilloma Virus →
- HPV-Related Cervical Carcinoma — all drugs for HPV-Related Cervical Carcinoma →
Sponsor
Universiteit Antwerpen — full company profile →
Who can join
Adults 25 to 64, female only, with Cervical Cancer or Cervical Intraepithelial Neoplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
DNA methylation as a triage tool for cervical cancer screening - A meeting report.
Burdier FR, Waheed DE, Nedjai B, Steenbergen RDM, et al · · 2024 · cited 20× · PMID 38524273 · DOI 10.1016/j.pmedr.2024.102678 -
Impact of Collection Volume and DNA Extraction Method on the Detection of Biomarkers and HPV DNA in First-Void Urine.
Téblick L, Van Keer S, De Smet A, Van Damme P, et al · · 2021 · cited 19× · PMID 33915837 · DOI 10.3390/molecules26071989 -
Clinical and Analytical Evaluation of the Abbott Alinity m HR HPV Assay in a New Generation First-Void Urine Collector.
Van Keer S, Téblick L, Donders G, Weyers S, et al · · 2025 · cited 3× · PMID 39981930 · DOI 10.1002/jmv.70254 -
Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study.
Hendrickx JO, Van Keer S, Donders G, Weyers S, et al · · 2025 · cited 3× · PMID 39934916 · DOI 10.1186/s13690-024-01490-3 -
Clinical performance of ASCL1/LHX8 DNA methylation on first-void urine to screen for cervical cancer.
Van Keer S, van den Helder R, Téblick L, De Smet A, et al · · 2026 · PMID 41820501 · DOI 10.1038/s43856-026-01512-x -
Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study
Hendrickx JO, Keer SV, Donders G, Weyers S, et al · · 2024 · DOI 10.21203/rs.3.rs-4430311/v1
Verify or expand the search:
- PubMed search for NCT04530201
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Universiteit Antwerpen trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04530201 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiteit Antwerpen
- Last refreshed: 15 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04530201.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing