RecruitingNot ApplicableNCT06598176

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

Developing a Combined Molecular Screening and Triage Test for Cervical Cancer Based on Human Papillomavirus (HPV) Detection, Quantification, Genotyping and DNA Methylation in Self-samples (COMBISCREEN)

Sponsor

Universiteit Antwerpen

Enrollment

100 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a new combined molecular screening test for cervical cancer that can be used on self-collected samples, which could make cervical cancer screening more accessible and less invasive. **You may be eligible if...** - You are a woman between 25 and 64 years old - You have been diagnosed with cervical cancer (CIN3 or worse stage) or are scheduled for a cervical procedure (conization) - You have not yet started any cancer treatment - You are able to understand the study information and give written consent **You may NOT be eligible if...** - You have had a hysterectomy (uterus removed) - You are pregnant or within 6 weeks of giving birth - You had treatment for cervical cancer or pre-cancer in the last 6 months - You are HIV positive, or have active hepatitis B or C - You have severe anemia or received a blood transfusion in the past 2 weeks - You are a known alcohol or drug abuser Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEColli-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).

DEVICEEvalyn 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.