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

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

NCT ID: NCT06598176

Condition: Uterine Cervical Neoplasm
Uterine Cervical Dysplasia
Human Papilloma Virus
HPV-Related Cervical Carcinoma

Conditions: Official terms:
Uterine Cervical Neoplasms
Papilloma
Uterine Cervical Dysplasia

Conditions: Keywords:
biomarker
first-void urine
vaginal sample
screening
triage
self-sampling
prevention

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Colli-Pee 20mL device with UCM
Description: 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).
Arm group label: Sample collection

Intervention type: Device
Intervention name: Evalyn Brush
Description: Women will collect a vaginal self-sample using the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before a hospital appointment.
Arm group label: Sample collection

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.

Criteria for 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.

Gender: Female

Minimum age: 25 Years

Maximum age: 64 Years

Healthy volunteers: No

Locations:

Facility:
Name: Universitair Ziekenhuis Antwerpen (UZA)

Address:
City: Edegem
Zip: 2650
Country: Belgium

Status: Recruiting

Contact:
Last name: Wiebren Tjalma, MD, PhD

Phone: 038213250

Phone ext: +32
Email: wiebren.tjalma@uza.be

Start date: March 28, 2024

Completion date: February 28, 2037

Lead sponsor:
Agency: Universiteit Antwerpen
Agency class: Other

Collaborator:
Agency: University Hospital, Antwerp
Agency class: Other

Source: Universiteit Antwerpen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06598176