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

Sponsor

Rennes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06041334

Collaborator

NeuroSphinx (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spina Bifida	Biological: Collection of a urine sample Diagnostic Test: Magnetic Resonance Imaging of the bladder	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Study volunteers	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)

Arm

Intervention/Treatment

Other: Study volunteers

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)

Outcome Measures

Primary Outcome Measures

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. [1 day]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.