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Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up

NCT06041334 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • Spina Bifida

Interventions

BIOLOGICAL

Collection of a urine sample

Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)

DIAGNOSTIC_TEST

Magnetic Resonance Imaging of the bladder

Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)

Sponsors & Collaborators

  • NeuroSphinx

    collaborator UNKNOWN

  • Rennes University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2027-07-18
Completion
2028-07-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06041334 on ClinicalTrials.gov