Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05347992
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fingerstick blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 423}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance between self collected samples and traditional venous draws', 'timeFrame': '36 months', 'description': 'Percentage of participants with concordant IFN-1 status as assessed by the DxTerity AIP IFN-1 module, concordance between phlebotomy draw and self-collected blood samples.'}], 'secondaryOutcomes': [{'measure': 'Longitudinal monitoring', 'timeFrame': '36 months', 'description': 'Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': "To explore the potential for use of DxTerity's AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information", 'detailedDescription': 'Explore and demonstrate concordance between self-collected samples and traditional phlebotomist venous draw for DxTerity AIP module and biomarkers like C3, C4, anti dsDNA and CRP in SLE participants with self-reported outcomes and medical record data.\n\nThe study will collect blood samples and self-reported information for SLE subjects, up to 5000 participants in Phase I, with a subset of 1000 continuing to Phase II with Medical records. Study participants will be recruited using a combination of digital media (including social media, advertising, bloggers, emails). Enrollment and qualification will be done along with consented retrieval of medical records using a study specific mobile app.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults diagnosed with SLE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: (PHASE I)\n\n1. Individuals aged 18 years or older.\n2. Must reside in United States\n3. Have a clinical diagnosis of SLE\n4. Willingness to consent to provide electronic medical records (EMR)\n5. Provide written informed consent and comply with the study procedures.\n\n(PHASE II)\n\n1. Verified diagnosis (Medical records or /and Physician Questionnaire) for SLE\n2. Report one or more of the following (record all that apply):\n\n 1. Worsening or changes in symptoms or flare\n 2. Changes in treatment regimen\n 3. On standard of care treatment\n 4. On biologics\n\nExclusion Criteria:\n\n1\\. Participants unable to complete study requirements'}, 'identificationModule': {'nctId': 'NCT05347992', 'acronym': 'ELEVATE', 'briefTitle': 'ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)', 'organization': {'class': 'INDUSTRY', 'fullName': 'DxTerity Diagnostics'}, 'officialTitle': 'ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)', 'orgStudyIdInfo': {'id': 'DXT-MCD-AI01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of Care', 'description': 'Cohort(1) of the study will collect longitudinal blood samples from participants who are on the standard of care treatment for Systemic lupus erythematosus (SLE) based on Cohort specific inclusion criteria'}, {'label': 'Biologics', 'description': 'Cohort(2) of the study will collect longitudinal blood samples from participants who are on biologics treatment for Systemic lupus erythematosus (SLE) based on Cohort specific inclusion criteria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90220', 'city': 'Compton', 'state': 'California', 'country': 'United States', 'facility': 'DxTerity Diagnostics, Inc.', 'geoPoint': {'lat': 33.89585, 'lon': -118.22007}}], 'overallOfficials': [{'name': 'Robert Terbrueggen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DxTerity Diagnostics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DxTerity Diagnostics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}