[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628032":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":28,"locations":11,"responsibleParty":39,"collaborators":11,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":11,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":11},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group : cancer patients developing neurological symptoms after starting treatment with immune","EXPERIMENTAL",null,[13],"Other: Lumbar puncture and blood sampling",{"label":15,"type":10,"description":11,"interventionNames":16},"Control group : cancer patients undergoing treatment with ICIs and experiencing neurological symptom",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Control group : patients with an autoimmune disease of the central nervous system",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Control group : patients with normal pressure hydrocephalus (NPH) or idiopathic intracranial hyperte",[13],[24],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Lumbar puncture and blood sampling","For all patients in the study, lumbar puncture will be performed as part of their care, according to the clinical indication given by the referring physician. If the patient gives their consent, an additional volume of CSF will be collected for this study, so that the total volume collected (care plus research) does not exceed 5 mL. No lumbar puncture will be performed specifically for the study.\n\nBlood samples will also be collected: these are additional blood tubes collected during a blood sample taken as part of the treatment (as described in the section 'Minimal risks and constraints added by the research').",[15,18,21,9],[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Stefania Cuzzubbo, MD","CONTACT","0171207467","+33","stefania.cuzzubbo@aphp.fr",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Jérôme Lambert, MD PhD","0142499742","jerome.lambert@u-paris.fr",{"type":40,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100628032","autoimmune-neurological-diseases-and-those-secondary-to-immunotherapy-study-of-immunological-mechanisms-and-research-into-targets-of-immune-attack-100628032",false,"NCT07456358","Autoimmune Neurological Diseases and Those Secondary to Immunotherapy: Study of Immunological Mechanisms and Research Into Targets of Immune Attack","Maladies Neurologiques Auto-immunes et Secondaires à l'immunothérapie : étude Des mécanismes Immunologiques et Recherche Des Cibles de l'Attaque Immune","DINAMIC","Inclusion Criteria:\n\n* Adult patient (aged ≥ 18 years)\n* Affiliated with a social security scheme\n* Express consent to participate in the study\n* Indication for lumbar puncture And\n* Patients with cancer, undergoing treatment with ICIs, presenting neurological symptoms after starting treatment with ICIs. These symptoms must have appeared no more than 3 months after the last administration of ICIs.\n\nOr\n\n* Patients with an autoimmune disease of the central nervous system (diagnosis made by teams 1, 2 and 3) according to internationally recognised criteria, with no history of active cancer in the last 3 years and no other autoimmune disease Or\n* Patients with normal pressure hydrocephalus (NPH) or idiopathic intracranial hypertension (diagnosed based on imaging (brain MRI) and clinical findings), with no history of active cancer in the last 3 years and no active autoimmune disease\n\nExclusion Criteria:\n\n* Contraindication or refusal to perform a lumbar puncture\n* Sample not suitable for research (volume of CSF collected for treatment \\>5 mL)\n* Corticosteroid therapy or other immunomodulatory treatment in progress (discontinued less than 15 days prior to inclusion)\n* Pregnant or breastfeeding women\n* Not affiliated with the social security system, patients under French State Medical Aid for undocumented migrants\n* Patients under guardianship or curatorship, under judicial protection measures, or deprived of their liberty by judicial or administrative decision",true,"ALL","18 Years",{"count":53,"type":54},160,"ESTIMATED","INTERVENTIONAL",[57],"NA","The pathophysiology of neurological toxicities secondary to immune checkpoint inhibitors (ICIs) is unknown. Various mechanisms have been proposed: activation of cytotoxic CD8 T cells, autoantibodies via activation of B cells and CD4 cells, non-specific inflammation through the production of pro-inflammatory cytokines, and complement activation.\n\nThe aim of this research is to characterise the pathophysiological mechanisms of neurotoxicities in cancer patients treated with ICIs.",[60,61],"Neurological Diseases","Auto Immune Disease",[63,64,65,66],"Autoimmune neurological diseases","Immunotherapy","Neurotoxocities","Immune checkpoint inhibitors","NOT_YET_RECRUITING","2026-03-04",{"date":70,"type":71},"2026-03-06","ACTUAL",{"date":73,"type":54},"2026-03-01",{"date":75,"type":54},"2030-11-01",{"name":5,"class":6}]