Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-05 @ 5:15 PM
Study NCT ID:
NCT05607368
Status:
RECRUITING
Last Update Posted:
2022-11-07
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in disease activity index', 'timeFrame': 'Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24', 'description': 'SLEDAI'}, {'measure': 'Numerical changes in markers such as tryptase, TLR4, and anti-NR2A antibodies in blood and cerebrospinal fluid', 'timeFrame': 'Baseline, months 3, 6, 9, 12, 15, 18, 21, and 24'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Erythematosus, Systemic']}, 'descriptionModule': {'briefSummary': 'Tryptase, TLR4, and anti-NR2A antibodies were measured in serum, cerebrospinal fluid, and subjects and other markers to assess their relevance to disease activity, aiming to find new therapeutic targets,Timely intervention to improve the prognosis of SLE and improve the quality of life of patients with SLE.', 'detailedDescription': "This study is a prospective cohort study: it is proposed to be divided into 3 groups, namely healthy control group and SLE group, NPSLE epilepsy group; Fifteen cases were included in each group, with the consent of the subjects and signed to know Consent form, record all subjects' clinical and laboratory test data, and test subjects' blood. Markers such as cerebrospinal fluid tryptase, TLR4 and anti-NR2A antibodies, follow-up 2 year, the patient's disease activity is evaluated every year, the change of indicators is dynamically observed, and statistical points are made divide."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Nanfang Hospital presents patients with systemic lupus erythematosus (SLE) and neuropsychiatric lupus(NPSLE) patients with epilepsy, as well as health examinations at the Health Management Center of Southern Hospital Healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy control group\n\n * Voluntary signing of informed consent;\n * Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender;\n * No systemic diseases or neurological symptoms or signs;\n * According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group.\n2. SLE group\n\n * Voluntary signing of informed consent;\n * Age greater than 18 years old, less than 50 years old, gender is not limited;\n * Patients with SLE who meet diagnostic criteria.\n3. NPSLE Epilepsy Group\n\n * Voluntary signing of informed consent;\n * Age greater than 18 years old, less than 50 years old, gender is not limited;\n * Patients with NPSLE epilepsy who meet diagnostic criteria.\n\nExclusion Criteria:\n\n1. SLE group\n\n * patients with SLE with other autoimmune diseases;\n * Previous seizures, psychiatric abnormalities and other manifestations;\n * MR of the head has obvious abnormal signals in the skull or EEG shows abnormal signals;\n * History of use of hormones and immunosuppressants;\n * The investigators judged that it was not suitable to participate in this study.\n2. NPSLE Epilepsy Group\n\n * prior history of epilepsy or clear cranial MR findings suggesting structural abnormalities;\n * Presence of precipitating seizures such as sleep deprivation, high fever, infection, long-term abstinence from alcoholism\n * Interrupt, patients with systemic diseases such as hypoglycemia, severe electrolyte disorders, malignant lesions, progressive or degenerative diseases, severe liver and kidney insufficiency and other metabolic diseases;\n * The investigators judged that it was not suitable to participate in this study."}, 'identificationModule': {'nctId': 'NCT05607368', 'briefTitle': 'Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Mast Cells Are Involved in the Mechanism of NPSLE Epilepsy', 'orgStudyIdInfo': {'id': 'NFEC-2022-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SLE group', 'description': '1. Voluntary signing of informed consent;\n2. Age greater than 18 years old, less than 50 years old, gender is not limited;\n3. Patients with SLE who meet diagnostic criteria.'}, {'label': 'NPSLE epilepsy group', 'description': '1. Voluntary signing of informed consent.\n2. Age greater than 18 years old, less than 50 years old, gender is not limited.\n3. Patients with NPSLE epilepsy who meet diagnostic criteria.'}, {'label': 'Healthy control group', 'description': "1. Voluntary signing of informed consent;\n2. Healthy volunteers older than 18 years old and less than 50 years old, regardless of gender;\n3. No systemic diseases and neurological symptoms and signs;\n4. According to the judge's judgment, healthy volunteers matching the NPSLE epilepsy group in terms of gender, age, and education level were selected as the control group."}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Huang', 'role': 'CONTACT', 'email': 'qinzihq@foxmail.com', 'phone': '13632430850'}], 'facility': 'Qin Huang', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qin Huang, Doctor', 'role': 'CONTACT', 'email': 'qinzihq@foxmail.com', 'phone': '13632430850'}], 'overallOfficials': [{'name': 'Qin Huang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'HUNAG QIN', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}