Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-24 @ 10:52 PM
Study NCT ID:
NCT05966350
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum collection for anti-FGFR3 antibody studies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies', 'timeFrame': '2 Years', 'description': 'Sensitivity-specificity of Argonaute (AGO) antibodies screening'}], 'secondaryOutcomes': [{'measure': 'Comparison of data between patients with anti-AGO antibodies versus patients without anti-AGO antibodies', 'timeFrame': '2 Years', 'description': 'Clinical pattern of the neuropathy in patients with anti-AGO antibodies versus patients without anti-AGO antibodies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sensory neuronopathy', 'Sensory ganglionopathy', 'Auto-antibody', 'Anti-AGO antibody'], 'conditions': ['Autoimmune Diseases']}, 'descriptionModule': {'briefSummary': 'Argonaute (AGO) proteins have been described as the target of antibodies in several autoimmune diseases including Sjögren Syndrome (SS). Sensory neuronopathies (SNN) are disorders affecting neurons in the dorsal root ganglia that may depend on an inflammatory process. However, identifying these cases needs the availability of specific biomarkers. The aim of this study is to test the prevalence of anti-AGO antibodies in a population of patients with Sensory neuronopathies (SNN) with and without associated autoimmune disease in comparison with other peripheral neuropathies to determine how anti-AGO antibodies may help the identification of potentially dysimmune Sensory neuronopathies (SNN).', 'detailedDescription': 'Sensory neuronopathies (SNN) are rare and debilitating diseases that fall under several etiologies. Among them, dysimmune forms are the most frequent but very difficult to identify when they do not occur in the context of associated systemic dysimmune disease (Sjögren Syndrome (SS) syndrome) because only a biopsy of the epiphytically unthinkable posterior spinal node would support the diagnosis. It is therefore necessary to have diagnostic biological markers of these forms to consider rapid treatment before irreversible neuronal degeneration.Using a protein-array technique, it has been showed that anti-FGFR3 antibodies was one of these markers and that it was associated with a clinical picture that differentiated from Sensory neuronopathies (SNN) without this antibody. Protein-array also allowed to identify another potentially interesting antibody for the diagnosis of Sensitive neuronopathies (NNS). This antibody recognizes the AGO1 protein. Anti-AGO1 antibodies have been described in association with system autoimmune diseases and in particular lupus but not in neurological diseases and more particularly in Sensory neuronopathies (SNN). The study want to validate the diagnostic interest of these antibodies by testing the collection of serums performed for studies on the anti-FGFR3 antibody and including patients with Sensory neuronopathies (SNN) and as controls of patients with another form of neuropathy and subjects with systemic autoimmune disease without peripheral neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sensory neuropathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with sensory neuropathy\n\nExclusion Criteria:\n\n* Patient not tested for anti-AGO antibody'}, 'identificationModule': {'nctId': 'NCT05966350', 'acronym': 'AGO', 'briefTitle': 'Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies', 'orgStudyIdInfo': {'id': 'IRBN742021/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sensory neuronopathies (SNN)', 'description': 'Patients with Sensory neuronopathies (SNN) will be included.', 'interventionNames': ['Diagnostic Test: Diagnosis of sensitive neuronopathy - phase 1', 'Diagnostic Test: Diagnosis of sensitive neuronopathy - phase 2', 'Other: Comparison with Chi2 method', 'Other: Comparison of data with parametric Test (T-test)', 'Other: Comparison of data with non-parametric test (ANNOVA)']}, {'label': 'another peripheral neuropathy', 'description': 'Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.', 'interventionNames': ['Diagnostic Test: Diagnosis of sensitive neuronopathy - phase 1', 'Diagnostic Test: Diagnosis of sensitive neuronopathy - phase 2', 'Other: Comparison with Chi2 method', 'Other: Comparison of data with parametric Test (T-test)', 'Other: Comparison of data with non-parametric test (ANNOVA)']}, {'label': 'dysimmune context without associated neuropathy.', 'description': 'Patient with dysimmune context without associated neuropathy will be included.', 'interventionNames': ['Diagnostic Test: Diagnosis of sensitive neuronopathy - phase 1', 'Diagnostic Test: Diagnosis of sensitive neuronopathy - phase 2', 'Other: Comparison with Chi2 method', 'Other: Comparison of data with parametric Test (T-test)', 'Other: Comparison of data with non-parametric test (ANNOVA)']}], 'interventions': [{'name': 'Diagnosis of sensitive neuronopathy - phase 1', 'type': 'DIAGNOSTIC_TEST', 'description': 'Search of positivity with anti-AGO antibodies test', 'armGroupLabels': ['Sensory neuronopathies (SNN)', 'another peripheral neuropathy', 'dysimmune context without associated neuropathy.']}, {'name': 'Diagnosis of sensitive neuronopathy - phase 2', 'type': 'DIAGNOSTIC_TEST', 'description': 'Title of anti-AGO antibodies', 'armGroupLabels': ['Sensory neuronopathies (SNN)', 'another peripheral neuropathy', 'dysimmune context without associated neuropathy.']}, {'name': 'Comparison with Chi2 method', 'type': 'OTHER', 'description': 'Clinical data from positive Argonaute (AGO) patients (age, sex, type of neuropathy, clinical manifestations of neuropathy, electroneuromyography , evolution of neuropathy, presence of associated autoimmune disease, response to possible immunomodulatory treatment) will be compared with those of negative patients using a Chi2 method for qualitative data.', 'armGroupLabels': ['Sensory neuronopathies (SNN)', 'another peripheral neuropathy', 'dysimmune context without associated neuropathy.']}, {'name': 'Comparison of data with parametric Test (T-test)', 'type': 'OTHER', 'description': 'Clinical data from positive Argonaute (AGO) patients (age, sex, type of neuropathy, clinical manifestations of neuropathy, electroneuromyography, evolution of neuropathy, presence of associated autoimmune disease, response to possible immunomodulatory treatment) will be compared with those of negative patients using a parametric test (T-test).', 'armGroupLabels': ['Sensory neuronopathies (SNN)', 'another peripheral neuropathy', 'dysimmune context without associated neuropathy.']}, {'name': 'Comparison of data with non-parametric test (ANNOVA)', 'type': 'OTHER', 'description': 'Clinical data from positive Argonaute (AGO) patients (age, sex, type of neuropathy, clinical manifestations of neuropathy, electroneuromyography , evolution of neuropathy, presence of associated autoimmune disease, response to possible immunomodulatory treatment) will be compared with those of negative patients using a non-parametric (ANNOVA).', 'armGroupLabels': ['Sensory neuronopathies (SNN)', 'another peripheral neuropathy', 'dysimmune context without associated neuropathy.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Jean-Christophe ANTOINE, MDPHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}