Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 7:39 AM
Study NCT ID:
NCT04963634
Status:
RECRUITING
Last Update Posted:
2022-04-12
First Post:
2021-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000799', 'term': 'Angioedema'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005820', 'term': 'Genetic Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare measurement by proteomics of proteins differentially expressed in the plasma by ANOVA t test', 'timeFrame': 'through study completion an average of 1 year', 'description': 'to evaluate the contribution of a plasma proteomic signature including albumin, gammaglobulin and alpha macroglobulin the plasma proteome of two group: Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)'}], 'secondaryOutcomes': [{'measure': 'analyze the following biomarkers for diagnostic purposes in both groups.', 'timeFrame': 'Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)', 'description': 'analyze the following biomarkers for diagnostic purposes: C1 inhibitor quantity'}, {'measure': 'the value of plasma proteome markers and the markers mentioned above as predictors of the occurrence of attacks', 'timeFrame': 'at 1 year'}, {'measure': 'Implementation of a biobank to identify future biomarkers', 'timeFrame': 'Enrollment (for group 1 and group 2) + 1 year visit (for group 1 only)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Angioedema', 'Bradykinin', 'Biomarker', 'Biobanking'], 'conditions': ['Angio Edema']}, 'descriptionModule': {'briefSummary': 'The unpredictable nature of the attacks is one of the essential characteristics of bradykinin angioedema. The two main difficulties for physicians managing a patient with bradykinin angioedema are to make the diagnosis and anticipate the severity.\n\nBiomarkers can be used to diagnose, guide treatment, or predict the severity of a disease. However, the identification of biomarkers is currently difficult in bradykinin both for diagnosis and prognosis. While measurement of C4 and C1 inhibitor (quantitative and functional assays) allows the diagnosis of bradykinin angioedema due to C1 inhibitor deficiency, whether genetic or acquired, many patients with normal C1 inhibitor bradykinin angioedema, either hereditary or acquired, are still difficult to diagnose. For patients with hereditary angioedema with C1-inhibitor deficiency, there is no biomarker currently available to predict the severity. Any biomarker that could improve the diagnosis on the one hand, and improve the prediction of the frequency and severity of the response to treatment on the other hand, would obviously be extremely useful. The aim of our study is to assess the existence possible biomarkers for diagnosis and prognosis of bradykinin angioedema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with bradykinin angioedema or histamine-mediated angioedema followed in internal medicine department of Lille University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1 : Patients with bradykinin angioedema\n* Patient with biologically proven hereditary angioedema with C1 inhibitor deficiency,\n* Or a patient with bradykinin angioedema related to a plasminogen or factor XII mutation,\n* Or patients with bradykinin angioedema related to ACE inhibitors or ARB2,\n* Or patient with acquired bradykinin angioedema due to C1 inhibitor deficiency,\n* Age \\> or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition\n* Having a blood collection scheduled as part of routine care\n* Being insured by social security\n\nGroup 2 : Patients with histamine-mediated angioedema\n\n* Patient with idiopathic histamine angioedema as determined by the referring physician\n* Age \\> or = 18 years with the capacity to understand the requirements of the study and to give a non-opposition\n* Having a blood collection scheduled as part of routine care\n* Being insured by social security\n\nExclusion Criteria:\n\n* Minors or protected adults,\n* Pregnant or breastfeeding woman,\n* Person deprived of liberty,\n* Person in an emergency situation,\n* Person having refused or unable to give their non-opposition'}, 'identificationModule': {'nctId': 'NCT04963634', 'acronym': 'BRADYDIAG', 'briefTitle': 'Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Research of Biomarkers Associated With the Diagnosis and Severity of Bradykinin Angioedema', 'orgStudyIdInfo': {'id': '2020_59'}, 'secondaryIdInfos': [{'id': '2020-A03306-33', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with bradykinin angioedema', 'interventionNames': ['Other: Biobanking']}, {'label': 'Patients with histamine-mediated angioedema', 'interventionNames': ['Other: Biobanking']}], 'interventions': [{'name': 'Biobanking', 'type': 'OTHER', 'otherNames': ['Biobanking without genetic analysis'], 'description': 'For patients included in BRADYDIAG study, 2 blood samples will be collected at enrollment (for group 1: bradykinin angioedema and for group 2: histamine-mediated angioedema) and at 1 year visit (for group 1 only: bradykinin angioedema).', 'armGroupLabels': ['Patients with bradykinin angioedema', 'Patients with histamine-mediated angioedema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0320445962'}], 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'David Launay, MD,PhD', 'role': 'CONTACT', 'email': 'david.launay@chru-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'David Launay, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}