Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-29 @ 11:03 AM
Study NCT ID:
NCT05738668
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2022-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical-immunological Features of Anti-NMDAR Encephalitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060426', 'term': 'Anti-N-Methyl-D-Aspartate Receptor Encephalitis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, DNA, cells, CSF collected at diagnosis time'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-12', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin scale (mRS)', 'timeFrame': 'Baseline', 'description': 'Scale for measuring the degree of dependence in the daily activities of people who have suffered of neurological disability.\n\n0 - No symptoms.\n\n1. \\- No significant disability. Able to carry out all usual activities, despite some symptoms.\n2. \\- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n3. \\- Moderate disability. Requires some help, but able to walk unassisted.\n4. \\- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n5. \\- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\n6. \\- Dead.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti NMDA Receptor Encephalitis', 'antibodies', 'relapses', 'outcomes'], 'conditions': ['Anti NMDA Receptor Encephalitis']}, 'descriptionModule': {'briefSummary': 'Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with well-characterized anti-NMDAR encephalitis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with neurological disorder\n* Patient with NMDAR antibodies in sera or CSF\n\nExclusion Criteria:\n\n* \\- No available clinical data\n* Patient without NMDAR antibodies or neurological disorder'}, 'identificationModule': {'nctId': 'NCT05738668', 'acronym': 'Bio-NMDAr', 'briefTitle': 'Clinical-immunological Features of Anti-NMDAR Encephalitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Clinical-immunological Features of Anti-NMDAR Encephalitis', 'orgStudyIdInfo': {'id': '750'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anti-NMDAR encephalitis', 'description': 'Patients with well-characterized anti-NMDAR encephalitis.', 'interventionNames': ['Other: Description of clinical characteristic']}], 'interventions': [{'name': 'Description of clinical characteristic', 'type': 'OTHER', 'description': 'This is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study.', 'armGroupLabels': ['Anti-NMDAR encephalitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Lyon', 'state': 'BRON', 'country': 'France', 'facility': 'Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}