Developing a new test for cervical cancer using self-collected samples

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HPV self-sampling in the ED to screen under-screened women

  This study tests whether giving an HPV self-sampling kit in the emergency department can help under-screened women get screened for cervical cancer and find those with HPV to guide follow-up care.

  Recruiting Rutgers, The State University of New Jersey · New Brunswick, New Jersey and 1 other locations · NCT07657104

• Dysplasix™ intravaginal suppositories for women with high‑risk HPV and mild cervical cell changes

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• CHW4CervixHealth: HPV self-collection kits with community health workers

  This project will test whether giving self-collection HPV kits during community workshops led by community health workers helps increase screening among under-screened women aged 25–65 and will first compare kit results to clinical Pap smears.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07336134

• Preventing cervical cancer with rapid HPV genotyping and same-day self-sampling

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• High resolution anal examination for HPV and anal cancer detection

  This study is testing how well high-resolution anal exams can help find high-risk HPV and anal cancer in people who are more likely to have these issues.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.