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

Launched by UNIVERSITEIT ANTWERPEN · Sep 13, 2024

Keywords

ClinConnect Summary

The COMBISCREEN project is a clinical trial aimed at developing a new test that can help screen for cervical cancer using self-collected samples. This means women can provide samples themselves, making the process easier and less invasive. The goal is to identify women who may have serious cervical conditions that require treatment, helping to catch issues early when they are most treatable.

To participate in this study, women must be between 25 and 64 years old and have been diagnosed with a significant cervical condition, such as cervical cancer or pre-cancer that needs treatment. It's important that they have not started any cancer treatment before joining the study. Participants will be asked to provide a sample and will receive information about what to expect throughout the trial. If you or someone you know meets these criteria and is interested, it's a great opportunity to contribute to important research in cervical health.

Gender

FEMALE

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.