Developing a new test for cervical cancer using self-collected 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)
This study is testing a new way to screen for cervical cancer using self-collected urine and vaginal samples to see if it works better than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 64 Years |
| Sex | Female |
| Sponsor | Universiteit Antwerpen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Edegem, Antwerpen) |
| Trial ID | NCT06598176 on ClinicalTrials.gov |
What this trial studies
The COMBISCREEN project aims to create a molecular screening and triage test for cervical cancer using self-collected urine and vaginal samples, which are non-invasive and easy to obtain. The study will collect various samples from women diagnosed with cervical cancer or those scheduled for conization to identify biomarkers associated with cervical cancer and cervical intraepithelial neoplasia (CIN). These samples will be analyzed for the presence of biomarkers such as HPV and DNA methylation, and the results will be compared to traditional cytology and histology methods to assess accuracy. This approach seeks to improve screening rates among women who are currently un(der)screened.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 25 to 64 who have been diagnosed with cervical cancer or require conization and have not yet started any cancer treatment.
Not a fit: Patients who have undergone a hysterectomy or are currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective screening method for cervical cancer, potentially increasing early detection rates.
How similar studies have performed: Other studies have shown promise in using self-collected samples for cervical cancer screening, indicating that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edegem, Antwerpen
- Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Antwerpen, Belgium (Recruiting)
Study contacts
- Principal investigator: Wiebren Tjalma, MD, PhD — Universiteit Antwerpen
- Study coordinator: Alex Vorsters, Ir, PhD
- Email: alex.vorsters@uantwerpen.be
- Phone: 032659130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.