Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT05041595
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lyme Disease Diagnostic Assay - Collection of Whole Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008193', 'term': 'Lyme Disease'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Performance - Sensitivity', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Diagnostic Sensitivity'}], 'secondaryOutcomes': [{'measure': 'Clinical Performance - Specificity', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Diagnostic Specificity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lyme Disease', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease.\n\nIn addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.', 'detailedDescription': 'Whole blood will be collected, and processed. Some blood will be transferred to additional tubes for further processing and aliquotting. Serum and plasma will be harvested and tested, at a later date, in a clinical performance study with approved and/or commercially available devices as well as an investigational Lyme assay. This study will be coordinated by the Sponsor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with suspected Borreliosis including subjects with EM rash and subjects without EM rash but with signs and symptoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease.\n\nHealthy subjects living in endemic Lyme disease area and healthy subjects living in a non-endemic Lyme disease area.', 'healthyVolunteers': True, 'eligibilityCriteria': "Subjects with under evaluation of Lyme Disease\n\nInclusion Criteria:\n\nSigns and symptoms of acute Lyme disease which include at least one of the following:\n\n* Recent onset of fatigue\n* Skin rash\n* Fever\n* Muscle aches\n* Neck pain\n* Joint pain or lymphadenopathy\n\nSubgroup Borreliosis Subjects- restricted signs and symptoms of acute Lyme including EM Rash\n\n* Under physician or medical evaluation for acute on-set of Lyme Disease presenting with EM Rash\n* Detailed description of the EM rash (e.g. Itchy, painful, hot, vesicular, raised) with consent for photographic documentation is required including additional picture with ruler placing to confirming size.\n* EM rash with the following attributes:\n\n * Size \\> 5 cm in diameter\n * Appeared 3-30 days after bite or suspected bite\n* Specify Location (e.g. underarm or back of knee)\n* Subjects with confirmed early localized or disseminated Lyme Borreliosis manifestation\n* Signs and symptoms (e.g. Fever, Chills/Sweats, Headache, Fatigue/Tiredness, Myalgia/Sore muscles)\n* The EM rash has been present \\<42 days\n* Clinical diagnosis of Lyme disease is suspected by the practitioner\n* Ability to provide the minimum sample volume required\n\nExclusion Criteria:\n\n* Subjects unable to provide informed consent.\n* Subjects without clinical information and/or not meeting inclusion criteria.\n* Subjects having started antibiotic treatment \\> 5 days before inclusion.\n\nHealthy Subjects\n\nInclusion Criteria:\n\n* Apparently healthy subjects with no present fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes, e.g. flu-like symptoms.\n* Ability to provide the minimum sample volume required.\n\nExclusion Criteria:\n\n\\- ● Subjects unable to provide informed consent\n\n* Subjects without clinical information and/or not meeting inclusion criteria\n* Subjects with a recent diagnosis of Lyme disease, Anaplasmosis, Babesiosis, or history of known embedded tick bite which may have required 'manual extraction' NOTE: a tick just found on the subject or presence of a crawling tick is not considered a 'tick bite')\n* Subjects currently on antibiotic treatment.\n* Uncontrolled HIV-infection, if known. This is defined as an HIV-1 viral load \\>40 copies/mL and/or CD4+ count \\<500 x 106 cells/liter in the past 12 months.\n* Active syphilis or leptospirosis, if known\n* Active infection with Epstein Barr Virus (mononucleosis), if known\n* Active infection with Cytomegalovirus (CMV), if known\n* Subjects with autoimmune diseases, either confirmed rheumatoid arthritis and/or other autoimmune disorders diagnosed according to the leading guidelines\n* Current immunomodulation mediation including \\>7.5 mg prednisone daily, methotrexate, and/or biologicals. Medications such as hydroxychloroquine, sulfasalazine or NSAIDs are acceptable.\n* Immunodeficiency, hematologic malignancies in the medical history\n* Chemotherapy during the past year"}, 'identificationModule': {'nctId': 'NCT05041595', 'briefTitle': 'Lyme Disease Diagnostic Assay - Collection of Whole Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'DiaSorin Inc.'}, 'officialTitle': 'Collection of Whole Blood to be Used to Provide the Safety and Effectivenss of a Lyme Disease Diagnostic Assay to Support the Proposed Intended Use Statement and Product Labeling Claims.', 'orgStudyIdInfo': {'id': 'PROT.648.00024.A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sick Cohort', 'description': 'Borreliosis Subjects - All comers expressing signs and symtoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease Borreliosis subjects with an Erythema Migrans Rash (subgroup)', 'interventionNames': ['Diagnostic Test: Lyme diagnostic assay']}, {'label': 'Apparently Healthy', 'description': 'Apparently healthy subjects living in an area non-endemic for Lyme disease Apparently healthy subjects living in an area endemic for Lyme disease', 'interventionNames': ['Diagnostic Test: Lyme diagnostic assay']}], 'interventions': [{'name': 'Lyme diagnostic assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serological and immunoresponse assay', 'armGroupLabels': ['Apparently Healthy', 'Sick Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55082', 'city': 'Stillwater', 'state': 'Minnesota', 'country': 'United States', 'facility': 'DiaSorin Inc.', 'geoPoint': {'lat': 45.05636, 'lon': -92.80604}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DiaSorin Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}