Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-27 @ 9:45 PM
Study NCT ID:
NCT04474132
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2020-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'subjects are recruited continuously and being tested with the study device as well as with the standard cleared test for the presence of Toxoplasma gondii antibody.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'congruence of Toxoplasma ICT IgG-IgM test and standard predicate test', 'timeFrame': 'two weeks for initial result and a year for whole study', 'description': 'Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['toxoplasma', 'test', 'feasibility'], 'conditions': ['Toxoplasma Infections']}, 'referencesModule': {'references': [{'pmid': '30114251', 'type': 'RESULT', 'citation': 'Lykins J, Li X, Levigne P, Zhou Y, El Bissati K, Clouser F, Wallon M, Morel F, Leahy K, El Mansouri B, Siddiqui M, Leong N, Michalowski M, Irwin E, Goodall P, Ismail M, Christmas M, Adlaoui EB, Rhajaoui M, Barkat A, Cong H, Begeman IJ, Lai BS, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Peyron F, McLeod R. Rapid, inexpensive, fingerstick, whole-blood, sensitive, specific, point-of-care test for anti-Toxoplasma antibodies. PLoS Negl Trop Dis. 2018 Aug 16;12(8):e0006536. doi: 10.1371/journal.pntd.0006536. eCollection 2018 Aug. No abstract available.'}, {'pmid': '28650970', 'type': 'RESULT', 'citation': 'Begeman IJ, Lykins J, Zhou Y, Lai BS, Levigne P, El Bissati K, Boyer K, Withers S, Clouser F, Noble AG, Rabiah P, Swisher CN, Heydemann PT, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Stillwaggon E, Peyron F, McLeod R. Point-of-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries. PLoS Negl Trop Dis. 2017 Jun 26;11(6):e0005670. doi: 10.1371/journal.pntd.0005670. eCollection 2017 Jun.'}, {'pmid': '30393749', 'type': 'RESULT', 'citation': 'Gomez CA, Budvytyte LN, Press C, Zhou L, McLeod R, Maldonado Y, Montoya JG, Contopoulos-Ioannidis DG. Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges. Open Forum Infect Dis. 2018 Oct 29;5(10):ofy215. doi: 10.1093/ofid/ofy215. eCollection 2018 Oct.'}, {'pmid': '38805559', 'type': 'DERIVED', 'citation': "Zhou Y, Leahy K, Grose A, Lykins J, Siddiqui M, Leong N, Goodall P, Withers S, Ashi K, Schrantz S, Tesic V, Abeleda AP, Beavis K, Clouser F, Ismail M, Christmas M, Piarroux R, Limonne D, Chapey E, Abraham S, Baird I, Thibodeau J, Boyer KM, Torres E, Conrey S, Wang K, Staat MA, Back N, L'Ollivier C, Mahinc C, Flori P, Gomez-Marin J, Peyron F, Houze S, Wallon M, McLeod R. Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. PLoS Negl Trop Dis. 2024 May 28;18(5):e0011335. doi: 10.1371/journal.pntd.0011335. eCollection 2024 May."}]}, 'descriptionModule': {'briefSummary': 'This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either pregnant or non pregnant.\n\nThis is being done in accordance with FDA requirements for clearance of a testing device . The investigators will use a standard FDA cleared test in all studies. The FDA has suggested that the investigators submit a pre subQ for a 510K and dual CLIA waiver.\n\nThis allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.', 'detailedDescription': 'This study will determine the feasibility of using the point of care Toxoplasma ICT IgG-IgM BK test produced by LD Bio Diagnostic to detect Toxoplasma gondii in clinical settings. The result of testing from Toxoplasma ICT IgG-IgM BK test will be compared with the standard predicate test. These results will be provided to FDA for consideration for clearance of this test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any adult who is willing to participate in the study\n\nExclusion Criteria:\n\n* pregnant women who are in their 17-27 weeks of gestation.'}, 'identificationModule': {'nctId': 'NCT04474132', 'briefTitle': 'Point of Care Testing for Presence of Current and or Previous T. Gondii Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection', 'orgStudyIdInfo': {'id': 'IRB20-0442'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'single group', 'description': 'binary: positive or negative result', 'interventionNames': ['Device: toxoplasma ICT IgG-IgM BK']}], 'interventions': [{'name': 'toxoplasma ICT IgG-IgM BK', 'type': 'DEVICE', 'description': 'a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody', 'armGroupLabels': ['single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rima McLeod, M.D.', 'role': 'CONTACT', 'email': 'rmcleod@uchicago.edu', 'phone': '312-513-6365'}, {'name': 'Marcela Cid', 'role': 'CONTACT', 'email': 'mcidrosas@uchicago.edu', 'phone': '714-376-4412'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Rima McLeod, M.D.', 'role': 'CONTACT', 'email': 'rmcleod@uchicago.edu', 'phone': '312-513-6365'}, {'name': 'Marcela Cid', 'role': 'CONTACT', 'email': 'mcidrosas@uchicago.edu', 'phone': '714-376-4412'}], 'overallOfficials': [{'name': 'Rima McLeod, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}