Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-27 @ 1:52 AM
Study NCT ID:
NCT05643092
Status:
RECRUITING
Last Update Posted:
2023-03-07
First Post:
2022-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-05', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of CAR-T-associated Neurotoxicity', 'timeFrame': 'up to 3 years post CAR T-cell infusion', 'description': 'The incidence of CAR-T-associated neurotoxicity of any grade defined by ASTCT'}], 'secondaryOutcomes': [{'measure': 'To identify biomarkers for ICANS', 'timeFrame': 'up to 1 years post CAR T-cell infusion', 'description': 'Serum and cerebrospinal fluid cytokines, neurocognitive assessments (Montreal Cognitive Assessment)'}, {'measure': 'MRI scans for ICANS', 'timeFrame': 'up to 1 years post CAR T-cell infusion', 'description': 'Lesion location associated with severity of ICANS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Effector Cell Associated Neurotoxicity Syndrome']}, 'descriptionModule': {'briefSummary': 'CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder.\n\nTo test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective observational study using a consecutive patient sample.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be ≥ 18 years of age at signing of informed consent.\n* Subjects are scheduled to receive CAR T-cell treatment.\n\nExclusion Criteria:\n\n* Refusal to sign the informed consent\n* Subjects having previously been treated with CAR-T therapy.\n* Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding\n* Subjects presenting primary CNS lymphoma\n* Pacemaker or other implanted electrical device incompatible with the MR environment\n* Subjects with a neurodegenerative disease (PD, AD)\n* Subjects with a previous or evolving neurological pathology\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT05643092', 'briefTitle': 'Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University'}, 'officialTitle': 'Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome', 'orgStudyIdInfo': {'id': '168'}}, 'contactsLocationsModule': {'locations': [{'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shoulong Zhang', 'role': 'CONTACT'}], 'facility': '980th Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'centralContacts': [{'name': 'Shoulong Zhang', 'role': 'CONTACT', 'email': 'longer_human007@126.com', 'phone': '86-0311-98224'}], 'overallOfficials': [{'name': 'Shoulong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '980th Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'zhang shoulong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinan Military General Hospital', 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'zhang shoulong', 'investigatorAffiliation': 'Hebei Medical University'}}}}