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Clinical Trials in Belgium / NCT07596316
Recruiting Observational

Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis

NCT07596316 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universiteit Antwerpen
Phase
Observational
Started
2025-12-10
Last updated
2026-05-19

Condition(s) studied

Chlamydia Trachomatis Genital Infection

Investigational drug(s) / intervention(s)

Sampling

Sampling: Collection of first-void urine (i.e. the initial stream of urine) with the Colli-Pee device (Novosanis, Belgium) (one sample of approx. 20 mL). Collection of a vaginal brush sample with the Evalyn brush (Rovers Medical Devices, The Netherlands). Collection of blood samples (three blood tubes of approx. 9 mL).

Study summary

The goal of this observational study is to learn if we can identify immune biomarkers in first-void urine and vaginal brush samples in Chlamydia trachomatis (CT) positive adult women. Participants will self-collect a first-void urine sample, self-collect a vaginal brush, and a blood sample will be collected by a healthcare worker. Participants will complete a questionnaire.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female * Chlamydia trachomatis NAAT positive vaginal sample or first-void urine sample. * Able to understand the information brochure and what the study is about. * Willing to give informed consent to use their samples for details described in the study protocol. Exclusion Criteria: * Pregnancy (self-reported) * Being positive for Human Immunodeficiency Virus (HIV) * Women that underwent hysterectomy. * Menstruation at the time of sample collection. * Current use of antibiotics effective against Chlamydia trachomatis (doxycyline or azithromycine) or use of such antimicrobials in the past 14 days before participating in the study. * Participating in another clinical trial at the same time of participating in this study. * 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.

Primary outcome measure(s)

  • Concentration of total and Chlamydia-specific immunoglobulins in first-void urine and serum samples — Within 6 months after study completion
    Concentration of total and Chlamydia-specific immunoglobulins in first-void urine and serum samples determined using ELISA-based assays and the correlation of antibody titers between both sample types.
  • Number of Chlamydia-specific SFCs per million cells — Within 6 months after study completion
    Quantification of antigen-specific cells in cells isolated from first-void urine samples, vaginal brush samples and whole blood samples (PBMC) using ELISpot-based assays.
  • Measurement of percentage and median fluorescence intensity (MFI) of immune cell subsets in blood, first-void urine and vaginal brush samples. — Within 6 months after study completion.
    Measuring percentage and MFI of immune cell subsets using flow cytometry

Trial sites (1)

FacilityCityRegionStatus
Violett Antwerp Antwerp Antwerp Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07596316 on ClinicalTrials.gov ↗ ← All trials in Belgium