Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-25 @ 2:37 PM
Study NCT ID:
NCT03948750
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2019-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014126', 'term': 'Toxoplasmosis, Ocular'}], 'ancestors': [{'id': 'D015822', 'term': 'Eye Infections, Parasitic'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014123', 'term': 'Toxoplasmosis'}, {'id': 'D003048', 'term': 'Coccidiosis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2014-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-10', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-10', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Goldmann-Witmer coefficient and immunoblotting results', 'timeFrame': 'Assessment of each test result at the inclusion of the patient', 'description': 'All tests realized in patients were performed before their repartition in the two groups as well as the biologist could not know the status of the patient. Sensitivity and specificity were calculated for each test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Toxoplasmosis']}, 'descriptionModule': {'briefSummary': 'Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.', 'detailedDescription': 'Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA.\n\nGWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum)\n\n0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, \\> 4: Diagnostic of intraocular antibody production to a specific microbial pathogen'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis\n\nExclusion Criteria:\n\n* Immunocompromised patients'}, 'identificationModule': {'nctId': 'NCT03948750', 'acronym': 'COPILOT', 'briefTitle': 'Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients', 'orgStudyIdInfo': {'id': 'COPILOT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Ocular Toxoplasmosis', 'interventionNames': ['Procedure: Aqueous humour sampling']}, {'label': 'Patients without Ocular Toxoplasmosis', 'interventionNames': ['Procedure: Aqueous humour sampling']}], 'interventions': [{'name': 'Aqueous humour sampling', 'type': 'PROCEDURE', 'description': 'Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting', 'armGroupLabels': ['Patients with Ocular Toxoplasmosis', 'Patients without Ocular Toxoplasmosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': "Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL)", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}