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

Spina Bifida Clinical Trial

— SPINLESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041334
• Other study ID #: 35RC20_9746_SPINLESS
• Secondary ID: IDRCB
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: January 18, 2026

Study information

• Verified date: January 2024
• Source: Rennes University Hospital
• Contact: LOÏC JACOB
• Phone: 0299282555
• Email: loic.jacob[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 18, 2026
• Est. primary completion date: January 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spina Bifida
• Spinal Dysraphism

Intervention

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)

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes cedex 9	CHU De Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	NeuroSphinx

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We will measure levels of the urinary biomarkers TIMP-2 and MMP-2 and we will report them to explain the Galloway score at the same time.	We will use logistic regression, with the variable to be explained being the Galloway score = 5 or > 5 (a qualitative variable with 2 classes) and the rate of urinary biomarkers as the explanatory variable	1 day