Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT04892134
Status:
UNKNOWN
Last Update Posted:
2023-10-19
First Post:
2021-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D018450', 'term': 'Disease Progression'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, peripheral blood mononuclear cells, DNA, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease', 'timeFrame': 'a maximum of 4 years', 'description': 'EDSS score'}], 'secondaryOutcomes': [{'measure': 'Prediction of clinical relapses', 'timeFrame': 'a maximum of 4 years', 'description': 'Prediction of clinical relapses'}, {'measure': 'Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteria', 'timeFrame': 'a maximum of 4 years', 'description': 'Conversion from CIS to MS defined by MRI and clinical criteria'}, {'measure': 'Time of transition to progressive form of MS', 'timeFrame': 'a maximum of 4 years', 'description': 'Time of transition to progressive form of MS'}, {'measure': 'Neuropsychological progression (decrease in SDMT performance)', 'timeFrame': 'a maximum of 4 years', 'description': 'Neuropsychological progression (decrease in SDMT performance)'}, {'measure': 'Increase in morphological damage (lesion load, atrophy)', 'timeFrame': 'a maximum of 4 years', 'description': 'Increase in morphological damage (lesion load, atrophy)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarker', 'progression', 'MRI', 'cognition'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained', 'detailedDescription': 'The current study aims to comprehensively investigate the individual clinical, morphological and biochemical aspects of MS in order to elucidate underlying mechanisms leading to disease progression. This shall ultimately serve to identify imaging and biochemical markers, which may support clinical management of persons with MS (pwMS). The following markers will be assessed: demographics (age, sex), clinical (EDSS at baseline, disease duration); neuropsychological (SDMT (Symbol Digit Modalities Test) score); MRI (Magnetic Resonance Imaging) (lesion load, atrophy); Biochemical markers analyzed in cerebrospinal fluid (CSF), blood, DNA, RNA, peripheral blood mononuclear cells (PBMCs)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria with suspected or proven multiple sclerosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected or proven multiple sclerosis\n* The participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria\n\nExclusion Criteria:\n\n* Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic'}, 'identificationModule': {'nctId': 'NCT04892134', 'briefTitle': 'Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS', 'orgStudyIdInfo': {'id': 'MarkMS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'description': '40-50 ml of blood is taken'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Enzinger, Prof.', 'role': 'CONTACT', 'email': 'chris.enzinger@medunigraz.at', 'phone': '+43/316/ 385-82180'}, {'name': 'Michael Khalil, MD', 'role': 'CONTACT', 'email': 'michael.khalil@medunigraz.at', 'phone': '+43/316/385-30313'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Christian Enzinger, Prof.', 'role': 'CONTACT', 'email': 'chris.enzinger@medunigraz.at', 'phone': '+43/316/ 385-82180'}, {'name': 'Michael Khalil, MD', 'role': 'CONTACT', 'email': 'michael.khalil@medunigraz.at', 'phone': '+43/316/385-30313'}], 'overallOfficials': [{'name': 'Christian Enzinger, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}