Clinical trial · Interventional
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)
NCT06598176CI-TRIAL-00080743COMBISCREENrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
| Human Papilloma Virus | — | UNRESOLVED | — |
| Uterine Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Uterine Cervical Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colli-Pee 20mL device with UCM | Device | — | UNRESOLVED |
| Evalyn Brush | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sample collection
- description
- Women will collect one first-void urine sample and one vaginal self-sample at home, one day prior to a scheduled appointment at the hospital. During the hospital visit, an additional clinician collected cervical smear and a blood sample will be collected for the study. In case, the patient also undergoes a surgical intervention for their standard treatment plan, the tissue that is collected there, will also be used and analysed for our study. Cytology and histology results will be used as reference test.
- interventionNames
- Device: Colli-Pee 20mL device with UCM
- Device: Evalyn Brush
Primary outcomes (1)
- measure
- Detection of (epi)genetic biomarkers for cervical cancer and precancer
- timeFrame
- 48 months
- description
- A novel assay will be developed for the detection of the human papillomavirus (HPV) and epigenetic biomarkers to determine the presence of cervical (pre)cancer. Using histology outcomes as a reference test.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.