RecruitingNot Applicable

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

Belgium73 participantsStarted 2025-12-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concentration of total and Chlamydia-specific immunoglobulins in first-void urine and serum samples

Timeframe: Within 6 months after study completion

Number of Chlamydia-specific SFCs per million cells

Timeframe: Within 6 months after study completion

Measurement of percentage and median fluorescence intensity (MFI) of immune cell subsets in blood, first-void urine and vaginal brush samples.

Timeframe: Within 6 months after study completion.

Trial details

NCT IDNCT07596316

SponsorUniversiteit Antwerpen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06

Contact for this trial

Anne Van Caesbroeck

+32 476 01 48 43 anne.vancaesbroeck@uantwerpen.be

View on ClinicalTrials.gov More Chlamydia Trachomatis Genital Infection trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Concentration of total and Chlamydia-specific immunoglobulins in first-void urine and serum samples

Timeframe: Within 6 months after study completion

Number of Chlamydia-specific SFCs per million cells

Timeframe: Within 6 months after study completion

Measurement of percentage and median fluorescence intensity (MFI) of immune cell subsets in blood, first-void urine and vaginal brush samples.

Timeframe: Within 6 months after study completion.