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Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples

NCT06598176 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-09-19

No results posted yet for this study

Summary

The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.

Conditions

  • Uterine Cervical Neoplasm
  • Uterine Cervical Dysplasia
  • Human Papilloma Virus
  • HPV-Related Cervical Carcinoma

Interventions

DEVICE

Colli-Pee 20mL device with UCM

Women will collect a first-void urine (the initial part of the urine stream) sample at home the day before a hospital appointment using the 20mL Colli-Pee device prefilled with urine conservation medium (UCM, Novosanis, Belgium).

DEVICE

Evalyn Brush

Women will collect a vaginal self-sample using the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before a hospital appointment.

Sponsors & Collaborators

  • University Hospital, Antwerp

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Wiebren Tjalma, MD, 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
2024-03-28
Primary Completion
2027-02-28
Completion
2037-02-28

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 NCT06598176 on ClinicalTrials.gov