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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2022-A02780-43 |
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| Name | Class |
|---|---|
| NeuroSphinx | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study volunteers | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of a urine sample | Biological | Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score | Logistic regression based on composite analysis of Galloway score (≤ 5 (low risk) or >5 (high risk)) and the rate of urinary biomarkers. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Galloway score | Change in Galloway score from baseline to 1 year based on change in urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 | 1 year |
| Success or failure of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LOÏC JACOB | Contact | 0299282555 | loic.jacob@chu-rennes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Recruiting | Rennes | CHU de Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| Magnetic Resonance Imaging of the bladder | Diagnostic Test | Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year) |
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The success of the treatment will be assessed at 1 year after its implementation according to an hybrid criteria : In the event of a Patients Global Impression of Improvement for Incontinence questionnaire < 3 and/or a Galloway score reduction of 1 or 2, the treatment will be considered successful.
| 1 year |
| Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers | The relationship between the success of the treatment implemented at inclusion and the level of the urinary biomarkers Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 at inclusion will be studied. | 1 year |
| Bladder hypocompliance based on metabolomic profile at inclusion | Presence or absence of bladder hypocompliance on urodynamic assessment at baseline, based on metabolomic profile at baseline. | 0 day |
| Bladder hypocompliance based on MRI radiomic markers at inclusion | Presence or absence of bladder hypocompliance on the urodynamic work-up at inclusion, based on MRI radiomic markers at inclusion. | 0 day |
| Bladder hypocompliance based on MRI radiomic markers at 1 year | Presence or absence of bladder hypocompliance on urodynamic assessment at 1 year according to MRI radiomic markers at 1 year | 1 year |
| Presence of biomarkers on bladder histological specimens | Presence of Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 biomarkers on bladder histological specimens based on levels of urinary Metalloproteinase Inhibitor 2 Anticorps and matrix metalloproteinase-2 biomarkers respectively. | From enrollment to 1 year |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |