Clinical trial · Observational
Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)
Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine: the AB-SOP Study
NCT02714114CI-TRIAL-00028139AB-SOPcompletedClinicalTrials.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 the study is to develop robust analytical protocols for first-void urine sample preparation and antibody assays to monitor natural and/or vaccine induced immunity against HPV (Human Papillomavirus).
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 Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Other | — | UNRESOLVED |
| First-void urine collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases: HPV vaccinated group
- description
- Women (18-26 years old) whom are previously vaccinated with the bivalent (Cervarix) or quadrivalent (Gardasil) prophylactic HPV vaccine. No clinical evaluations will be performed.
- interventionNames
- Other: First-void urine collection
- Other: Blood draw
- label
- Controls: HPV unvaccinated group
- description
- Women (18-26 years old) whom are not vaccinated with the bivalent (Cervarix) or quadrivalent (Gardasil) prophylactic HPV vaccine. No clinical evaluations will be performed.
- interventionNames
- Other: First-void urine collection
- Other: Blood draw
Primary outcomes (1)
- measure
- Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 18-26 year * Cases (n=38): healthy women, fully vaccinated, i.e. receiving all three doses of the bivalent (Cervarix®) or quadrivalent (Gardasil®) HPV vaccine (according to the KCE (Belgian Knowledge Centre for Health) recommendations: age at first vaccination between 10-25 years for the bivalent and 9-26 years for the quadrivalent vaccine). * Cases should be able to prove their vaccination (brand and schedule) with an official document. * Control group (n=19): healthy women, self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available (Gardasil®, Cervarix®, Gardasil-9®) * Signing informed consent form (ICF). * Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF). Exclusion Criteria: * Participating in another clinical study at the same time of participating in this study. * Not able to understand the information brochure/what the study is about * Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
References
Publications (1)
- DERIVEDVan Keer S, Willhauck-Fleckenstein M, Pattyn J, Butt J, Tjalma WAA, Van Ostade X, Hens N, Van Damme P, Waterboer T, Vorsters A. First-void urine as a non-invasive liquid biopsy source to detect vaccine-induced human papillomavirus antibodies originating from cervicovaginal secretions. J Clin Virol. 2019 Aug;117:11-18. doi: 10.1016/j.jcv.2019.05.004. Epub 2019 May 11. PMID 31129514