Evaluating urinary biomarkers in spina bifida patients
Official title: Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Run by Rennes University Hospital · NCT06041334 · Data updated 2026-11-12
This study is testing if certain urine markers can help predict kidney damage in people with spina bifida during their regular check-ups.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes, CHU de Rennes) |
| Status | Recruiting |
| Started | January 18, 2024 |
| Main results expected | July 18, 2027 |
| Study ends | July 18, 2028 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06041334 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with spina bifida who are undergoing regular multidisciplinary consultations at a rare disease reference center.
✕Probably not a fit
Patients with certain urinary diversions, untreated infections, or specific urinary tract histories may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the potential of urinary biomarkers, specifically TIMP-2 and MMP-2, to predict the risk of upper urinary tract damage in patients with spina bifida. Participants will have their biomarkers measured during routine urodynamic assessments, which are part of their regular follow-up care. The study aims to correlate these biomarkers with the Galloway score, a measure of kidney health, to enhance monitoring and management of renal function in this patient population.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of kidney damage in spina bifida patients, allowing for timely interventions.
How similar studies have gone: While the approach of using urinary biomarkers is promising, the specific application in spina bifida is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spina patients consulted as part of the multidisciplinary consultation of the spina bifida rare disease reference centre; * Written consent to participate in the research. * Compulsory membership of a social security scheme Exclusion Criteria: * Patients with a non-continuous trans ileal urinary diversion ; * Patients with enterocystoplasty; * Untreated bacteriuria at the time of urodynamic assessment and urine sample collection; * History of urinary tract tumour; * History of histologically proven interstitial cystitis; * Persons under legal protection (safeguard of justice, curatorship, guardianship); * Persons deprived of their liberty. * Women claiming to be pregnant
Where it's running
-
Rennes University Hospital
Rennes, CHU de Rennes, France Recruiting
Study contacts
- Study coordinator: Loïc Jacob
- Email: loic.jacob@chu-rennes.fr
- Phone: 0299282555
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.