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

NCT ID: NCT06598176

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2037-02-28

Brief 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.

Detailed Description

Currently, there is still 37% of the Flemish population eligible for cervical cancer screening that remains un(der)screened. Self-collected urine and vaginal samples that can be collected from home and are non-invasive provide an attractive alternative for this group. The aim of this study is to collect different samples from patients with a cervical cancer or a scheduled conization in order to identify potential biomarkers for cervical cancer and cervical intraepithelial neoplasia (CIN). These samples include a home-collected first-void urine (Colli-Pee 20mL prefilled with urine conservation medium (UCM)) and vaginal self-sample (Evalyn Brush), as well as a clinician collected cervical smear, blood sample and when appropriate also a tissue sample. A tissue sample will only be collected when the patient is undergoing surgical procedures for their standard therapy. As such, they do not undergo additional invasive procedures as part of the study. The samples are collected prior to starting therapeutic processes (e.g. conization, chemotherapy, radiotherapy, surgery…). The presence of biomarkers (e.g. human papillomavirus (HPV) and DNA methylation) for cervical cancer and cervical intraepithelial neoplasia (CIN) will be determined and compared in each of the sample types. The results of the biomarker assays will also be compared to clinical results from cytology and histology in order to determine the accuracy.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sample collection

Women will collect one first-void urine sample and one vaginal self-sample at home, one day prior to a scheduled appointment at the hospital. During the hospital visit, an additional clinician collected cervical smear and a blood sample will be collected for the study. In case, the patient also undergoes a surgical intervention for their standard treatment plan, the tissue that is collected there, will also be used and analysed for our study. Cytology and histology results will be used as reference test.

Group Type: EXPERIMENTAL

Colli-Pee 20mL device with UCM

Intervention Type: DEVICE

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).

Evalyn Brush

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Female
• 25 until 64 years old
• Diagnosed with cervical cancer (CIN3+, irrespective of stage) OR in need of conization (irrespective of diagnostic or therapeutic purposes)
• Has not started any form of cancer treatment prior to study enrollment
• Written informed consent must be obtained from patient
• Is able to understand the information brochure and what the study is about

Exclusion Criteria

• Women that underwent hysterectomy
• Pregnant women or 6 weeks post-partum
• Treatment for cervical (pre)cancer in the last 6 months before participation in the study
• Participating in another interventional clinical study (where e.g., a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.
• Unable to give informed consent
• Patient has severe anaemia
• Patient received blood transfusion two weeks before sample collection
• Blood sampling would compromise patients' overall health
• Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
• Patients who are alcoholic or drug abusers
• Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Wiebren Tjalma

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wiebren Tjalma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerpen, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Alex Vorsters, Ir, PhD

Role: CONTACT

alex.vorsters@uantwerpen.be

032659130 ext. +32

Eef van den Borst, MSc

Role: CONTACT

eef.vandenborst@uantwerpen.be

032652665 ext. +32

Facility Contacts

Wiebren Tjalma, MD, PhD

Role: primary

wiebren.tjalma@uza.be

038213250 ext. +32

Other Identifiers

B3002023000030

Identifier Type: -

Identifier Source: org_study_id