MedTrace Logo

CASUS: Improved and Quality Assured Collection of First-void Urine

NCT04480866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-07-21

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Colli-Pee® (FV5000 and Small Volumes)

Colli-Pee® device (Novosanis, Belgium) attached to collector tubes prefilled with a non-toxic nucleic acid preservative (including an internal process control). The collector tubes differ in size to collect a total sample volume of 4, 10, and 20 mL. Each participant will collect three urine samples using the Colli-Pee Small Volumes 4 and 10 mL, and the Colli-Pee FV5000 (20 mL) device, in a random order.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Novosanis NV

    collaborator INDUSTRY

  • Self-screen B.V.

    collaborator UNKNOWN

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Pierre Van Damme, MD, PhD · Universiteit Antwerpen

  • Alex Vorsters, Ir, PhD · Universiteit Antwerpen

  • Severien Van Keer, PhD · Universiteit Antwerpen

  • Laura Téblick, Ir · Universiteit Antwerpen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2019-11-25
Completion
2019-11-27

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480866 on ClinicalTrials.gov