Back to resultsEvaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up (SPINLESS)
Primary Purpose
Spina Bifida
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of a urine sample
Magnetic Resonance Imaging of the bladder
Sponsored by
About this trial
This is an interventional prevention trial for Spina Bifida focused on measuring Spina Bifida, urinary biomarker, upper urinary tract, Galloway score, urodynamic work-up, urethrocystography
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.
Sites / Locations
- Rennes University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study volunteers
Arm Description
Outcomes
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06041334
First Posted
September 7, 2023
Last Updated
September 14, 2023
Sponsor
Rennes University Hospital
Collaborators
NeuroSphinx
1. Study Identification
Unique Protocol Identification Number
NCT06041334
Brief Title
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Acronym
SPINLESS
Official Title
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
NeuroSphinx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida
Keywords
Spina Bifida, urinary biomarker, upper urinary tract, Galloway score, urodynamic work-up, urethrocystography
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study volunteers
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Collection of a urine sample
Intervention Description
Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Imaging of the bladder
Intervention Description
Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LOÏC JACOB
Phone
0299282555
Email
loic.jacob@chu-rennes.fr
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes cedex 9
State/Province
CHU De Rennes
ZIP/Postal Code
35033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Haudebert, MD
Email
Camille.HAUDEBERT@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Benoit Peyronnet, MD
Email
Benoit.PEYRONNET@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Benoit Peyronnet, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
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