Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 7:06 AM
Study NCT ID:
NCT06041334
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2023-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016135', 'term': 'Spinal Dysraphism'}], 'ancestors': [{'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-07-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score', 'timeFrame': '1 day', 'description': 'Logistic regression based on composite analysis of Galloway score (≤ 5 (low risk) or \\>5 (high risk)) and the rate of urinary biomarkers.'}], 'secondaryOutcomes': [{'measure': 'Galloway score', 'timeFrame': '1 year', 'description': 'Change in Galloway score from baseline to 1 year based on change in urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2'}, {'measure': 'Success or failure of treatment', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Bladder hypocompliance based on metabolomic profile at inclusion', 'timeFrame': '0 day', 'description': 'Presence or absence of bladder hypocompliance on urodynamic assessment at baseline, based on metabolomic profile at baseline.'}, {'measure': 'Bladder hypocompliance based on MRI radiomic markers at inclusion', 'timeFrame': '0 day', 'description': 'Presence or absence of bladder hypocompliance on the urodynamic work-up at inclusion, based on MRI radiomic markers at inclusion.'}, {'measure': 'Bladder hypocompliance based on MRI radiomic markers at 1 year', 'timeFrame': '1 year', 'description': 'Presence or absence of bladder hypocompliance on urodynamic assessment at 1 year according to MRI radiomic markers at 1 year'}, {'measure': 'Presence of biomarkers on bladder histological specimens', 'timeFrame': 'From enrollment to 1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spina Bifida', 'urinary biomarker', 'upper urinary tract', 'Galloway score', 'urodynamic work-up', 'urethrocystography'], 'conditions': ['Spina Bifida']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nVolunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spina patients consulted as part of the multidisciplinary consultation of the spina bifida rare disease reference centre;\n* Written consent to participate in the research.\n* Compulsory membership of a social security scheme\n\nExclusion Criteria:\n\n* Patients with a non-continuous trans ileal urinary diversion ;\n* Patients with enterocystoplasty;\n* Untreated bacteriuria at the time of urodynamic assessment and urine sample collection;\n* History of urinary tract tumour;\n* History of histologically proven interstitial cystitis;\n* Persons under legal protection (safeguard of justice, curatorship, guardianship);\n* Persons deprived of their liberty.\n* Women claiming to be pregnant'}, 'identificationModule': {'nctId': 'NCT06041334', 'acronym': 'SPINLESS', 'briefTitle': 'Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up', 'orgStudyIdInfo': {'id': '35RC20_9746_SPINLESS'}, 'secondaryIdInfos': [{'id': 'IDRCB', 'type': 'OTHER', 'domain': '2022-A02780-43'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study volunteers', 'interventionNames': ['Biological: Collection of a urine sample', 'Diagnostic Test: Magnetic Resonance Imaging of the bladder']}], 'interventions': [{'name': 'Collection of a urine sample', 'type': 'BIOLOGICAL', 'description': 'Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)', 'armGroupLabels': ['Study volunteers']}, {'name': 'Magnetic Resonance Imaging of the bladder', 'type': 'DIAGNOSTIC_TEST', 'description': 'Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)', 'armGroupLabels': ['Study volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'state': 'CHU de Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle SAMSON, MD', 'role': 'CONTACT', 'email': 'emmanuelle.samson@chu-rennes.fr', 'phone': '33299289763'}, {'name': 'Benoit Peyronnet, MD', 'role': 'CONTACT', 'email': 'Benoit.PEYRONNET@chu-rennes.fr', 'phoneExt': '33299289763'}, {'name': 'Emmanuelle SAMSON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'LOÏC JACOB', 'role': 'CONTACT', 'email': 'loic.jacob@chu-rennes.fr', 'phone': '0299282555'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeuroSphinx', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}