Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-26 @ 9:50 PM
Study NCT ID:
NCT05745792
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2023-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, PBMCs, DNA, CSF and tumor collected at the time of diagnosis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', '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': '2023-02', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2023-02-12', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Scale (mRs)', 'timeFrame': 'At 1 year', 'description': 'Application of modified rankin scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PARANEOPLASTIC NEUROLOGICAL DISORDERS', 'LUNG CANCER', 'HU AUTOIMMUNITY', 'IMMUNE TOLERANCE BREAKDOWN'], 'conditions': ['Immune Tolerance']}, 'descriptionModule': {'briefSummary': 'Phenotypic characterization of patients with Hu-Abs, including the different neurological presentation and the presence or not of an underlying cancer.\n\nAnalysis and clinical correlation of the diagnostic techniques for Hu-Abs detection (immunofluorescence, immunodot/Western blot, and CBA) in serum and/or CSF.\n\nGenomic and transcriptomic features of tumors (histological and immune infiltrate characteristics, transcriptomic profile, mutational status).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients harboring Hu Abs in serum and/or CSF with or without cancer', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria \\* :\n\n * Patient with neurological disorder\n * Patient with Hu antibody in sera or CSF\n* Exclusion Criteria \\* :\n\n * Patient with no data\n * Patient without neurological disorder\n * Patient without Hu antibody in sera/CSF'}, 'identificationModule': {'nctId': 'NCT05745792', 'acronym': 'CarTo-Hu', 'briefTitle': 'Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity', 'orgStudyIdInfo': {'id': '751'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Hu Abs', 'description': 'Patients harboring Hu Abs and a neurological syndrome', 'interventionNames': ['Other: Description of clinical, immunological and tumor features of patients harboring Hu Abs']}], 'interventions': [{'name': 'Description of clinical, immunological and tumor features of patients harboring Hu Abs', 'type': 'OTHER', 'description': 'This observationnal study involves clinical data and bio. samples (DNA and tumors block). Demographic and clinical data already in French Reference Center on PNS database will be reviewed. Additional data will be obtained from the referral physicians. The results of diagnostic tests performed to detect Hu-Abs in the patients are already in this database and will be retrospectively analyzed. In addition, the 4 available techniques (immunofluorescence, commercial immunodot, Western blot, and CBA) will be performed from Jan. 2022 to Dec. 2022.Tumor samples from 2 cohorts will be analyzed: (i) tumors of patients with Hu-Abs and PNS, and (ii) tumors of patients without PNS (mostly SCLC). After selecting patients, the study will involve 3 steps: (i) pathological confirmation; (ii) DNA sequencing and CNV analysis (panel of genes involved in anti-Hu autoimmunity; mainly ELAVL1 to 4, encoding for HuA to HuD, the 4 main proteins of the Hu family); and (iii) whole-genome RNA sequencing.', 'armGroupLabels': ['Patients with Hu Abs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}