CASUS: Validation for Detection of Precursor Lesions

NACompletedINTERVENTIONAL
Enrollment

332

Participants

Timeline

Start Date

August 20, 2020

Primary Completion Date

October 20, 2021

Study Completion Date

February 28, 2022

Conditions
Cervical CancerCervical Intraepithelial NeoplasiaHuman Papilloma VirusHPV-Related Cervical CarcinomaUrine
Interventions
DEVICE

Colli-Pee Small Volumes (10 mL) device

Women will self-collect two first-void urine samples at home the day prior to colposcopy using the new generation Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube will be prefilled with a non-toxic nucleic acid preservative including an internal process control.

Trial Locations (3)

3300

Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen, Tienen

4030

Gynécologie-obstétrique - CHU de Liège, Liège

9000

Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent), Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amsterdam UMC, location VUmc

OTHER

collaborator

Novosanis NV

INDUSTRY

collaborator

Self-screen B.V.

UNKNOWN

lead

Universiteit Antwerpen

OTHER

NCT04530201 - CASUS: Validation for Detection of Precursor Lesions | Biotech Hunter | Biotech Hunter