RecruitingNCT06582654

Normalizing Antibody Detection in First-void Urine

URINORM: Normalizing Antibody Detection in First-void Urine

Sponsor

Universiteit Antwerpen

Enrollment

150 participants

Start Date

Dec 7, 2023

Study Type

OBSERVATIONAL

Conditions

Human Papillomavirus Infection

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 fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.

Eligibility

Min Age: 9 YearsMax Age: 70 Years

Inclusion Criteria3

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 Criteria5

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.

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Interventions

DEVICESampling

Collection of first-void urine (i.e. the initial stream of the urine) with the Colli-Pee device (Novosanis, Belgium) (6-21 samples over a period of 36 days). Collection of blood samples (2 samples, at day 1 and 36 of the study).