Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 6:13 AM
Study NCT ID:
NCT04210960
Status:
UNKNOWN
Last Update Posted:
2019-12-27
First Post:
2019-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Serum Lactate and Activity of 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2019-12-22', 'studyFirstSubmitQcDate': '2019-12-22', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical testing', 'timeFrame': '2 days', 'description': 'Plasma lactate was assayed according to Trinder method14 . All assays were carried out with Bechman Coulter AU480 autoanalyzer (USA).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis, serum lactate and MRS'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '33657991', 'type': 'DERIVED', 'citation': 'Esmael A, Talaat M, Egila H, Eltoukhy K. Mitochondrial dysfunction and serum lactate as a biomarker for the progression and disability in MS and its correlation with the radiological findings. Neurol Res. 2021 Jul;43(7):582-590. doi: 10.1080/01616412.2021.1893567. Epub 2021 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS', 'detailedDescription': 'Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS and magentic resonanace imaging , magentic resonanace spectroscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '80 Egyptian subjects (50 multiple sclerosis patients (patients group = group I) and 30 normal healthy control (control group = group II)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients with multiple sclerosis (RRMS,PPMS and SPMS)\n\nExclusion Criteria:\n\n-Patients with any other medical conditions that may affect the serum lactate level'}, 'identificationModule': {'nctId': 'NCT04210960', 'briefTitle': 'Correlation of Serum Lactate and Activity of Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University Hospital'}, 'officialTitle': 'Correlation of Serum Lactate and Activity of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'Mansoura University H 10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients group', 'description': '50 multiple sclerosis patients', 'interventionNames': ['Radiation: Magentic resonanace imaging', 'Radiation: Magentic resonanace spectroscopy']}, {'label': 'Control group', 'description': '30 normal healthy control', 'interventionNames': ['Radiation: Magentic resonanace imaging', 'Radiation: Magentic resonanace spectroscopy']}], 'interventions': [{'name': 'Magentic resonanace imaging', 'type': 'RADIATION', 'description': 'The brain MR imaging examinations were done by using a 3 tesla scanner (Acheiva; Philips Medical Systems, Best, Netherlands). All patients were examined in the supine position using head coil. Routine images (T2, T1, FLAIR) and double inversion recovery sequence (DIR) were done to all patients: repetition time (TR) \\_ 9583 sec, echo time (TE) \\_ 25 sec, inversion time (TI) \\_ 3400 sec, IR delay \\_ 325 sec, echo train length (ETL) \\_ 17, 50 contiguous axial slices, thickness \\_ 3 mm, matrix size 240× 142 mm2, field of view (FOV) 230× 184 mm2.', 'armGroupLabels': ['Control group', 'Patients group']}, {'name': 'Magentic resonanace spectroscopy', 'type': 'RADIATION', 'description': 'Magnetic Resonance (MR) spectroscopy is a noninvasive diagnostic test for measuring biochemical changes in the brain.While magnetic resonance imaging (MRI) identifies the anatomical location of a lesion, MR spectroscopy compares the chemical composition of normal brain tissue with abnormal brain tissue. This test can also be used to detect tissue changes in stroke and epilepsy.', 'armGroupLabels': ['Control group', 'Patients group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Esmael M Ahmed, MD', 'role': 'CONTACT', 'email': 'deltaneuro@yahoo.com', 'phone': '00201000382898'}], 'facility': 'Mansoura University Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Esmael M Ahmed, MD', 'role': 'CONTACT', 'email': 'deltaneuro@yahoo.com', 'phone': '00201000372787'}], 'overallOfficials': [{'name': 'Esmael M Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Prof of Neurology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Prof of Neurology', 'investigatorFullName': 'Ahmed Esmael', 'investigatorAffiliation': 'Mansoura University Hospital'}}}}