Status:
RECRUITING
Normalizing Antibody Detection in First-void Urine
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
University Hospital, Antwerp
Conditions:
Human Papillomavirus Infection
Eligibility:
All Genders
9-70 years
Brief Summary
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 fluctua...
Detailed Description
To date, invasive clinician-collected cervical samples, blood, and vaginal samples are still the primary methods to monitor disease and immune responses to vaccine-preventable genital tract infections...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06582654
Start Date
December 7 2023
End Date
January 1 2026
Last Update
September 3 2024
Active Locations (1)
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1
University of Antwerp
Edegem, Antwerp, Belgium, 2650