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CASUS: Validation for Detection of Precursor Lesions

NCT04530201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2022-06-15

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 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.

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

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2021-10-20
Completion
2022-02-28

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 NCT04530201 on ClinicalTrials.gov