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

NCT ID: NCT06041334

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-18

Study Completion Date

2028-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Spina Bifida

Keywords

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Spina Bifida urinary biomarker upper urinary tract Galloway score urodynamic work-up urethrocystography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study volunteers

Group Type OTHER

Collection of a urine sample

Intervention Type BIOLOGICAL

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

Magnetic Resonance Imaging of the bladder

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Collection of a urine sample

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

Intervention Type BIOLOGICAL

Magnetic Resonance Imaging of the bladder

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeuroSphinx

UNKNOWN

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rennes University Hospital

Rennes, CHU de Rennes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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LOÏC JACOB

Role: CONTACT

Phone: 0299282555

Email: [email protected]

Facility Contacts

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Emmanuelle SAMSON, MD

Role: primary

Benoit Peyronnet, MD

Role: backup

Other Identifiers

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35RC20_9746_SPINLESS

Identifier Type: -

Identifier Source: org_study_id

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id