Clinical trial · Observational
First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
Detection of Biomarkers in First-void Urine Samples for Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)
NCT03542513CI-TRIAL-00091002completedClinicalTrials.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 aim of this study is to analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (CIN).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colli-Pee | Device | — | UNRESOLVED |
| Qvintip | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- hrHPV DNA status of self-collected first-void urine and vaginal samples vs physician sampled cervical specimens.
- timeFrame
- Within 6 months after study completion
- description
- Concordance hrHPV DNA status of self-collected first-void urine and vaginal samples from women treated for high-grade cervical lesions to that of physician sampled cervical specimens.
Secondary outcomes (4)
- measure
- hrHPV DNA status of self-collected first-void urine and vaginal samples at home vs at the hospital.
- timeFrame
- Within 6 months after study completion
- description
- Concordance hrHPV DNA status of self-collected first-void urine and vaginal fluid samples at home to self-collected samples at the hospital.
- measure
- Effect of treatment on HPV DNA presence.
- timeFrame
- Within 6 months after study completion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Female (18 years and older) * Scheduled for LLETZ treatment of diagnosed, histologically confirmed high grade CIN lesions * Giving informed consent to the research team (CEV) to contact his/her GP and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy. * Not participating in another clinical study where a drug or biological is administered. * Able to understand the information brochure/what the study is about.
References
Publications (0)
Data not yet available
No reference posted for this study.