NCT06598176Recruiting
Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-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)
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Sept 2024
- Start date
- 28 Mar 2024
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Universiteit Antwerpen
- Diseases
- Cervical cancer
- NCT number
- NCT06598176
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 28 Mar 2024 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Patient received blood transfusion two weeks before sample collection
- Patients who are alcoholic or drug abusers
Other illness
- Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- 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.
Other
- Women that underwent hysterectomy
- Pregnant women or 6 weeks post-partum
- Unable to give informed consent
- Patient has severe anaemia
- Blood sampling would compromise patients' overall health
Who the study is looking for
- 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
Age in the registry: 25 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Antwerpen (Uza) Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.