Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT04789551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
T Cell Profiling in Patients with Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T cell populations', 'timeFrame': 'up to one week', 'description': 'compare T cell populations between patients with Multiple Sclerosis and healthy controls'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "The goal of this research study is to to learn more about the body's immune response in patients with multiple sclerosis (MS). In MS, the body's immune cells mistakenly attack an important part of the nerves of the brain and spinal cord. The immune cells responsible for attacking the nerves in MS patients is primarily the T cells. A marker was recently discovered that might specifically identify these damaging T cells from all other T cells in the body. Understanding which T cells cause the damage in MS patients and understanding more about these specific T cells may help doctors better understand how MS occurs and could possibly prevent MS in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Multiple Sclerosis who present to Boston Children's Hospital will be enrolled. A group of healthy control patients who present for elective surgery at Boston Children's Hospital will also be enrolled.", 'healthyVolunteers': False, 'eligibilityCriteria': 'MS Group Inclusion criteria\n\n-diagnosis of multiple sclerosis and present to the neurology clinic for a regular checkup or are admitted to the inpatient floor with acute symptoms.\n\nExclusion criteria\n\n* Have an active infection\n* Take T cell modulating drugs\n\nControl Group Inclusion criteria -scheduled for elective surgery\n\n* without any immunological diseases. Exclusion criteria\n* Have an active infection.'}, 'identificationModule': {'nctId': 'NCT04789551', 'briefTitle': 'T Cell Profiling in Patients with Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'T Cell Profiling in Patients with Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'IRB-P00037843'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Sclerosis Stable Conditions', 'description': 'Multiple sclerosis patients presenting for a routine clinic visit.', 'interventionNames': ['Other: Blood Sample']}, {'label': 'Multiple Sclerosis Acute Flare Up', 'description': 'Multiple sclerosis patients admitted to the hospital with acute symptoms.', 'interventionNames': ['Other: Blood Sample']}, {'label': 'Control patients', 'description': 'Patients without any immunological diseases who present for elective surgery.', 'interventionNames': ['Other: Blood Sample']}], 'interventions': [{'name': 'Blood Sample', 'type': 'OTHER', 'description': 'a blood sample will be collected', 'armGroupLabels': ['Control patients', 'Multiple Sclerosis Acute Flare Up', 'Multiple Sclerosis Stable Conditions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Lifei Hou, PhD', 'role': 'CONTACT', 'email': 'lifei.hou@childrens.harvard.edu'}, {'name': 'Koichi Yuki, MD', 'role': 'CONTACT', 'email': 'koichi.yuki@childrens.harvard.edu', 'phone': '617-355-6225'}], 'facility': "Boston Children's Hopsital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Lifei Hou, PhD', 'role': 'CONTACT', 'email': 'lifei.hou@childrens.harvard.edu', 'phone': '617-713-8154'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lifei Hou', 'investigatorAffiliation': "Boston Children's Hospital"}}}}