Clinical trial · Observational
Normalizing Antibody Detection in First-void Urine
URINORM: Normalizing Antibody Detection in First-void Urine
NCT06582654CI-TRIAL-00080358URINORMunknownClinicalTrials.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 develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.
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 |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sampling | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Pre-adolescent group
- description
- Defined as girls between 9 and 14 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not yet menstruating (pre-menarche).
- interventionNames
- Device: Sampling
- label
- Ovulatory group
- description
- Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are not using any hormone- or ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle.
- interventionNames
- Device: Sampling
- label
- Ovulation-influencing contraceptive group
- description
- Defined as women between 18 and 30 years old, who are vaccinated against HPV with either the Cervarix, Gardasil or Gardasil9 vaccine and are using ovulation-influencing contraceptives that impact hormonal levels during the menstrual cycle (including oral contraceptives, hormonal ring, contraceptive injection, contraceptive patch, hormonal implant).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Vaccinated with either the Cervarix, Gardasil or Gardasil9 HPV-vaccine and able to present vaccination booklet or another official document proving this. * Able to understand the information brochure and what the study is about. * Willing to give informed consent to contact his/her general practitioner and/or gynecologist to access details on their HPV vaccination schedule and, in case a woman within the screening population, cervical cancer screening results (smears, HPV tests, colposcopy, biopsy). Exclusion Criteria: * Participating in another clinical trial at the same time of participating in this study. * Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the six months prior to study enrolment. * Pregnant women. * Being positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C. * Having 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 individual to participate, in the opinion of the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.