Clinical trial NCT06598176: Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Cervical Neoplasm
Uterine Cervical Dysplasia
Human Papilloma Virus
HPV-Related Cervical Carcinoma
Keywords: biomarker
first-void urine
vaginal sample
screening
triage
self-sampling
prevention
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2024-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Detection of (epi)genetic biomarkers for cervical cancer and precancer
timeFrame: 48 months
Secondary outcomes:
measure: Comparison of the biomarkers detected in the different sample types.
timeFrame: 48 months
measure: Demonstrate non-inferiority of the biomarker assay in self-samples compared to conventional cytology on pap smears.
timeFrame: 48 months
measure: Determine the predictive value of the biomarker assay and the long-term risk of cervical (pre)cancer
timeFrame: Within 1 year after study completion
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (UZA)
state: Antwerpen
Study officials:
affiliation: Universiteit Antwerpen
name: Wiebren Tjalma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: