Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-01 @ 8:04 AM
Study NCT ID:
NCT02769767
Status:
UNKNOWN
Last Update Posted:
2016-05-12
First Post:
2016-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polymorphisms of Interleukins, Glypican, and Human Leukocyte Antigen Genes and Treatment Response in Multiple Sclerosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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': 'D053673', 'term': 'Glypicans'}], 'ancestors': [{'id': 'D058851', 'term': 'GPI-Linked Proteins'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019812', 'term': 'Heparan Sulfate Proteoglycans'}, {'id': 'D011509', 'term': 'Proteoglycans'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D058635', 'term': 'Lipid-Linked Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Total blood for posterior extraction of DNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response evaluated by relapses per year, evaluated during two years after recruitment.', 'timeFrame': 'Two Years', 'description': 'Treatment response evaluated by relapses per year during two years after recruitment. The relapses are defined by any neurological sign or symptom that happens at least 30 days after any previous neurological deterioration episode began.'}, {'measure': 'Treatment response evaluated by Expanded Disability Status Scale (EDSS) during two years after recruitment.', 'timeFrame': 'Two Years', 'description': 'Treatment response evaluated by Expanded Disability Status Scale (EDSS) during two years after recruitment.\n\nThe EDSS scale ranges from 0 to 10; the increments are in 0.5. Scoring is based on an examination by a neurologist about the level of disability.'}], 'secondaryOutcomes': [{'measure': 'Multiple Sclerosis Risk Conferred by Single Nucleotide Polymorphisms (SNPs) of Interleukins, Glypican, and Human Leukocyte Antigen Genes.', 'timeFrame': 'One Year', 'description': 'The risk conferred by SNPs of Interleukins, Glypican, and Human Leukocyte Antigen Genes: calculated by odds ratio when the allele frequencies of SNPs cases are compared with the allele frequencies of SNPs in healthy subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'descriptionModule': {'briefSummary': 'HLA-DRB1 \\* Gene and some genes involved in inflammation and immunity (IL-7R, GPC5, CTSS) have been linked to risk of MS and the response to treatment with immunomodulators. This research aims to estimate the risk that confers some variations in the sequence of these genes.', 'detailedDescription': 'Genes HLA-DRB1 \\* and some genes involved in inflammation and immunity have been linked to risk of MS and the response to treatment with immunomodulators.\n\nThe HLA-DRB1 \\* genes have been associated with risk and response to treatment in MS in multiple studies; however, other genes have been controversial. This research aims to estimate the risk for MS that confers some variations in the sequence of IL-7R, GPC5, CTSS, HLA-DRB1 genes. Furthermore, it seeks to determine whether these gene variants (polymorphisms) are associated with treatment response to immunomodulators.\n\nSubjects with MS and healthy subjects will be taken to assess the risk for MS. Besides the investigators obtain the medical history of relapse to assess response to treatment in accordance with Expanded Disability Status Scale (EDSS) and relapses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with multiple sclerosis and healthy subjects were studied. In subjects with multiple sclerosis, the number of relapses and EDSS was evaluated for two years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Cases:\n\n* Subjects with multiple sclerosis\n* 18 and over\n* EDSS less than 5\n* Signed informed consent\n\nInclusion Criteria for Controls:\n\n* Healthy subjects\n* 18 and over\n* Signed informed consent\n\nExclusion Criteria for Cases:\n\n* Mental retardation\n* Withdrawal of consent\n* No immunomodulatory treatment\n\nExclusion Criteria for Controls:\n\n* Mental retardation\n* Withdrawal of consent'}, 'identificationModule': {'nctId': 'NCT02769767', 'acronym': 'WESTEMDRB1', 'briefTitle': 'Polymorphisms of Interleukins, Glypican, and Human Leukocyte Antigen Genes and Treatment Response in Multiple Sclerosis.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Jalisciense de Cancerologia'}, 'officialTitle': 'Association of Polymorphisms of the Interleukin-7 Receptor-α (IL-7R), Glypican 5 (GPC5), Interleukin-2 Receptor-α (IL2-RA) , Human Leukocyte Antigen Class II Beta Chain (HLA-DRB1) Genes and Treatment Response in Multiple Sclerosis (MS).', 'orgStudyIdInfo': {'id': 'EM-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Subjects with Relapsing-Remitting Multiple Sclerosis. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.', 'interventionNames': ['Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.']}, {'label': 'Controls', 'description': 'Healthy subjects. Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.', 'interventionNames': ['Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.']}, {'label': 'Responders', 'description': 'Subjects with MS treated for at least two years that have less than one relapse per year or who had an increase of \\<1.5 points on the Expanded Disability Status Scale (EDSS) (if baseline EDSS was 0) or no increase in EDSS (baseline EDSS ≥1). Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.', 'interventionNames': ['Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.']}, {'label': 'No responders', 'description': 'Subjects with MS that have more than one relapse per year treated for at least two years, and who had ≥1 relapse(s) or an increase of 1.5 points on the EDSS (if baseline EDSS was 0) or an increase of ≥0.5 points (baseline EDSS ≥1). Polymorphisms frequencies of Interleukins, Glypican, and Human Leukocyte Antigen Genes are determined.', 'interventionNames': ['Genetic: Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.']}], 'interventions': [{'name': 'Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.', 'type': 'GENETIC', 'description': 'The frequencies of the polymorphic variants in subjects with MS and healthy subjects were evaluated. Also in subjects with MS, the response to treatment with the number of relapses and EDSS was assessed; to compare the allele frequencies of SNPs of Interleukins, Glypican, and Human Leukocyte Antigen Genes, between responders and no responders MS patients.', 'armGroupLabels': ['Cases', 'Controls', 'No responders', 'Responders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'JOSE A. CRUZ RAMOS, PhD', 'role': 'CONTACT', 'email': 'josealfonsocr@gmail.com', 'phone': '0152 3314886313'}], 'facility': 'Instituto Jalisciense de Cancerología', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'centralContacts': [{'name': 'JOSE A. CRUZ RAMOS, PhD', 'role': 'CONTACT', 'email': 'josealfonsocr@gmail.com', 'phone': '0152 3314886313'}, {'name': 'EMMANUEL DE LA MORA JIMENEZ, PhD', 'role': 'CONTACT', 'email': 'moraej@hotmail.com', 'phone': '0152 36580556'}], 'overallOfficials': [{'name': 'JOSE A. CRUZ RAMOS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Jalisciense de Cancerología'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Jalisciense de Cancerologia', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, {'name': 'University of Guadalajara', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Jose Alfonso Cruz-Ramos', 'investigatorAffiliation': 'Instituto Jalisciense de Cancerologia'}}}}