Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Recruiting now · Not applicable
Conditions studied: Spina Bifida
In brief
The aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly. The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated. Volunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.
Key facts
- Study ID
- NCT06041334
- Run by
- Rennes University Hospital
- People needed
- 50
- Starts
- 2024-01-18
- Expected to finish
- 2028-07-18
- Last updated by the study team
- 2025-12-22
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Rennes University Hospital — Rennes, CHU de Rennes, France (enrolling)
Full record on ClinicalTrials.gov
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