[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519268":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":25,"locations":31,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Rennes University Hospital","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Study volunteers",null,[12,13],"Biological: Collection of a urine sample","Diagnostic Test: Magnetic Resonance Imaging of the bladder",[15,20],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"BIOLOGICAL","Collection of a urine sample","Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)",[9],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Magnetic Resonance Imaging of the bladder","Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"LOÏC JACOB","CONTACT","0299282555","loic.jacob@chu-rennes.fr",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Rennes","CHU de Rennes","35033","France","FR",{"type":40,"coordinates":41},"Point",[42,43],-1.67431,48.11109,{"lat":43,"lon":42},[46,50,53],{"name":47,"role":28,"phone":48,"phoneExt":10,"email":49},"Emmanuelle SAMSON, MD","33299289763","emmanuelle.samson@chu-rennes.fr",{"name":51,"role":28,"phone":10,"phoneExt":48,"email":52},"Benoit Peyronnet, MD","Benoit.PEYRONNET@chu-rennes.fr",{"name":47,"role":54,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[58],{"name":59,"class":60},"NeuroSphinx","UNKNOWN","100519268","evaluation-of-multimodal-and-non-invasive-spina-bifida-neurovessels-during-prospective-follow-up-100519268",false,"NCT06041334","Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up","SPINLESS","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","ALL","6 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78],"Spina Bifida",[78,80,81,82,83,84],"urinary biomarker","upper urinary tract","Galloway score","urodynamic work-up","urethrocystography","2025-12-15",{"date":87,"type":88},"2025-12-22","ACTUAL",{"date":90,"type":88},"2024-01-18",{"date":92,"type":72},"2028-07-18",{"name":5,"class":6},1]