Evaluating urinary biomarkers in spina bifida patients
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes, CHU de Rennes) |
| Trial ID | NCT06041334 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with spina bifida who are undergoing regular multidisciplinary consultations at a rare disease reference center.
Not a fit: Patients with certain urinary diversions, untreated infections, or specific urinary tract histories may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rennes, CHU de Rennes
- Rennes University Hospital — Rennes, CHU de Rennes, France (Recruiting)
Study contacts
- Study coordinator: Loïc Jacob
- Email: loic.jacob@chu-rennes.fr
- Phone: 0299282555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.