Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-25 @ 3:48 AM
Study NCT ID:
NCT03316404
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2017-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)', 'timeFrame': '2 years', 'description': 'Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS) to develop a blood test to characterize MS status by analyzing gene expression from blood samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'MS'], 'conditions': ['Multiple Sclerosis', 'MS']}, 'descriptionModule': {'briefSummary': "To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.", 'detailedDescription': 'Multiple Sclerosis (MS) is an autoimmune disease that damages the central nervous system (CNS) and disrupts communication to and from the brain by attacking the myelin sheath surrounding neurons. It impairs control of bodily functions and leads to clinical disability as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically develops in young adults; primarily women in their early 30s. The etiology of MS is not fully understood, but it is noted that the prevalence of MS differs with geography and ethnicity.\n\nBiomarker signature panels are important tools for monitoring treatment response and screening for individuals who are unlikely to benefit from certain therapies. To establish a baseline and further characterize gene expression in MS, blood samples from individuals with MS will be collected. A rapid blood test to predict a treatment response would be an innovative diagnostic product that could aid in identifying individuals that may benefit from the targeted therapy. In the long term, such a test could bring significant clinical benefits by enabling individualized treatment to better control the disease, unburdening healthcare costs, and dramatically improving the management of MS.\n\nIn order to analyze gene expression data from individuals diagnosed with MS, the study will collect blood samples and information from up to 1500 subjects for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with Multiple Sclerosis (MS)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients age 18 or older\n* Have a permanent address in the United States for the duration of the study\n* Have an email address and access to the internet for the duration of the study\n* Able to provide informed consent\n* Self-reported diagnosis of MS\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03316404', 'acronym': 'EMPOWER', 'briefTitle': 'Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'DxTerity Diagnostics'}, 'officialTitle': 'Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response', 'orgStudyIdInfo': {'id': 'DXT-MCD-AD02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Cohort 1 of the study will collect blood samples from participants in various states of the disease. After qualification and informed consent, accepted participants will be sent a blood collection kit and will be asked to complete a study-related questionnaire.'}, {'label': 'Cohort 2', 'description': 'Cohort 2 may be conducted at selected clinical sites where MS treatment-naïve patients who are entering a new treatment paradigm will be sought. At the clinical site, patients will be qualified, consented, and a small amount (up to 1mL) of blood will be collected. Between approximately 1 week and 6 months of treatment on the new drug, the participant will be sent another blood collection kit for microsample collection and a brief questionnaire at home. A final sample will be collected between 3 and 6 months after the start of treatment. Within 6 months of initiating treatment, the site will be asked to provide information regarding the health and treatment status of the participant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90220', 'city': 'Compton', 'state': 'California', 'country': 'United States', 'facility': 'DxTerity Diagnostics', 'geoPoint': {'lat': 33.89585, 'lon': -118.22007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DxTerity Diagnostics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}