NCT06041334 Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
| NCT ID | NCT06041334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Spina Bifida |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2027-07-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-18 with a primary completion date of 2027-07-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06041334 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Spina Bifida. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06041334 currently recruiting?
Yes, NCT06041334 is actively recruiting participants. Contact the research team at loic.jacob@chu-rennes.fr for enrollment information.
Where is the NCT06041334 trial being conducted?
This trial is being conducted at Rennes, France.
Who is sponsoring the NCT06041334 clinical trial?
NCT06041334 is sponsored by Rennes University Hospital. The trial plans to enroll 50 participants.