Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT05077956
Status:
WITHDRAWN
Last Update Posted:
2023-08-07
First Post:
2021-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'C564597', 'term': 'Cone-Rod Dystrophy 10'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sema4A is measured in serum and CSF by a Sema-4A-specific ELISA (Biomatik). Frozen serum and CSF samples will be sent to laboratory at Penn State for these measurements. Whole blood and CSF will be obtained from each subject at the screening/baseline visit, with follow-up whole blood at 6 and 12 months in patient Groups 1-3. We will also measure myelin basic protein levels in the CSF and measure lymphocyte subsets in whole blood for Groups 1-3. These two tests will be performed by the Providence clinical lab.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No participants were enrolled before closing the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Serum Semaphorin 4A Levels', 'timeFrame': 'Baseline', 'description': 'Measure blood serum semaphorin 4A levels at baseline'}, {'measure': 'Cerebrospinal Fluid Semaphorin 4A Levels', 'timeFrame': 'Baseline', 'description': 'Measure cerebrospinal fluid semaphorin 4A levels at baseline'}], 'secondaryOutcomes': [{'measure': 'Correlation between Semaphorin 4A levels and Demyelination and Axonal Degeneration', 'timeFrame': '12 Months', 'description': 'MRI will be performed at 6 months and 12 months to evaluate if there is a correlation between baseline semaphorin 4 A levels and demyelination and axonal degeneration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'relapsing multiple sclerosis', 'semaphorin 4A', 'sema4a', 'disease modifying therapy', 'biomarker'], 'conditions': ['Relapsing Multiple Sclerosis', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).', 'detailedDescription': 'This pilot study proposal will further investigate whether Semaphorin 4A (Sema4A) elevation in cerebrospinal fluid (CSF) and serum is a potential disease activity biomarker in patients with multiple sclerosis (MS).\n\nA total of 40 female subjects between the ages of 18-55 who meet the criteria of one of the following four groups will be enrolled to measure serum and CSF Sema4A levels:\n\n* Group 1: Newly diagnosed/untreated Relapsing MS patients (RMS)\n* Group 2: Clinically stable RMS patients receiving disease modifying therapy (DMT)\n* Group 3: RMS patients receiving DMT with breakthrough disease\n* Group 4: Non-MS controls (patients without inflammatory CNS disease)\n\nParticipants will provide blood and CSF samples at baseline for Sema4A analysis. Follow up blood samples will be collected at 6 months and 12 months as part of lymphocyte subset analysis. Participation will end after 12 months of follow up.\n\nThe expected risks are related to blood draws and lumbar puncture. Lumbar puncture will be performed under fluoroscopy to decrease risks of pain from repeated needle punctures, injury from incorrect placement of the needle, and post puncture CSF leakage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Multiple sclerosis and non-MS controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged 18-55, inclusive at the time of consent\n* Not pregnant at the time of the screening/baseline visit\n* Able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able and provide informed consent in English\n* Meet the criteria of one of the four groups at the time of consent:\n\n * Group 1: subjects who have recently been diagnosed with MS, have had a clinical attack within the last 6 months, have not received steroids in the last 30 days, and have not started on a disease modifying therapy\n * Group 2: subjects with clinically stable relapsing MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks, who are receiving a FDA-approved MS DMT\n * Group 3: subjects with relapsing MS on a FDA-approved DMT but with evidence of breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord MRI taken within the 4 weeks\n * Group 4: subjects without evidence of inflammatory systemic or CNS disease, who require CSF removal for some other cause, such as for idiopathic intracranial hypertension or communicating hydrocephalus\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study.'}, 'identificationModule': {'nctId': 'NCT05077956', 'acronym': 'Sema4A MS', 'briefTitle': 'Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Providence Health & Services'}, 'officialTitle': 'Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis', 'orgStudyIdInfo': {'id': '2021000250'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recently Diagnosed Multiple Sclerosis', 'description': 'Recently diagnosed MS, who have had a clinical attack within the last 6 months, have not received steroids in the last 30 days, and have not started on a disease modifying therapy (DMT).', 'interventionNames': ['Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels']}, {'label': 'Clinically Stable Relapsing Multiple Sclerosis', 'description': 'Clinically stable relapsing MS, who are receiving a FDA-approved MS DMT and have had no evidence of a clinical relapse for at least the past 12 weeks or gadolinium enhancing lesions on MRI in the prior 4 weeks.', 'interventionNames': ['Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels']}, {'label': 'Relapsing Multiple Sclerosis on Disease Modifying Therapy', 'description': 'Relapsing MS on a FDA-approved DMT with evidence of recent breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord MRI taken within the 4 weeks.', 'interventionNames': ['Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels']}, {'label': 'Healthy Volunteers', 'description': 'Patients without evidence of inflammatory systemic or CNS disease, who require CSF removal for some other cause, such as for idiopathic intracranial hypertension or communicating hydrocephalus.', 'interventionNames': ['Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels']}], 'interventions': [{'name': 'Cerebrospinal and Blood Serum Semaphorin 4A Levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.', 'armGroupLabels': ['Clinically Stable Relapsing Multiple Sclerosis', 'Healthy Volunteers', 'Recently Diagnosed Multiple Sclerosis', 'Relapsing Multiple Sclerosis on Disease Modifying Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Stanley Cohan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence Health and Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence Health & Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}