Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 6:37 PM
Study NCT ID:
NCT04070612
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D000744', 'term': 'Anemia, Hemolytic, Autoimmune'}, {'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2012-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-27', 'studyFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete sustainable remission (yes/no) for children with autoimmune haemolytic anemias', 'timeFrame': 'At the screening', 'description': 'Absence of clinical signs of anemia (grade 0) And Hemoglobin \\> 11 g / dl And reticulocytes \\<120,000 / mm3 And haptoglobin\\> 10 mg / dl And bilirubin \\<10 mg / l or 17 μmol / l And no specific treatment for at least 12 months'}, {'measure': 'complete remission (yes/no) for children with autoimmune haemolytic anemias', 'timeFrame': 'At the screening', 'description': 'Absence of clinical signs of anemia (grade 0) And Hemoglobin\\> 11 g / dl And reticulocytes \\<120,000 / mm3 Regardless of the level of haptoglobin or bilirubin And specific treatment in progress or interrupted for less than 12 months'}, {'measure': 'partial remission (yes/no) for children with autoimmune haemolytic anemias', 'timeFrame': 'At the screening', 'description': 'Clinical Signs of Anemia (Grade 1 or 2) Or Hemoglobin from 7 to 11 g / dl Or reticulocytes\\> 120,000 / mm3 Regardless of the level of haptoglobin or bilirubin'}, {'measure': 'no response (yes/no) for children with autoimmune haemolytic anemias', 'timeFrame': 'At the screening', 'description': 'Clinical Signs of Severe Anemia (Grade 3 or More) Or Hemoglobin \\<7 g / dl'}, {'measure': 'deceased patient (yes/no) for children with autoimmune haemolytic anemias', 'timeFrame': 'At the screening', 'description': 'Death yes/no'}, {'measure': 'Complete sustainable remission (yes/no) for children with chronic immunologic thrombocytopenic purpura', 'timeFrame': 'At the screening', 'description': 'Absence of clinical signs of haemorrhage (grade 0) And platelets\\> 100,000 / mm3 And no specific treatment for at least 12 months'}, {'measure': 'complete remission (yes/no) for children with chronic immunologic thrombocytopenic purpura', 'timeFrame': 'At the screening', 'description': 'Absence of clinical signs of haemorrhage (grade 0) And platelets\\> 100,000 / mm3 And specific treatment in progress or interrupted for less than 12 months'}, {'measure': 'partial remission (yes/no) for children with chronic immunologic thrombocytopenic purpura', 'timeFrame': 'At the screening', 'description': 'Clinical Signs of Hemorrhage (Grade 1 or 2) Or platelets between 30,000 and 100,000 / mm3'}, {'measure': 'no response (yes/no) for children with chronic immunologic thrombocytopenic purpura', 'timeFrame': 'At the screening', 'description': 'Clinical Signs of Severe Hemorrhage (Grade 3 or Greater) Or Platelets \\<30,000 / mm3'}, {'measure': 'deceased patient (yes/no) for children with chronic immunologic thrombocytopenic purpura', 'timeFrame': 'At the screening', 'description': 'Death yes/no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children'], 'conditions': ['Cytopenia', 'Autoimmune Haemolytic Anaemia', 'Thrombocytopenic Purpura, Immune']}, 'descriptionModule': {'briefSummary': 'This study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.', 'detailedDescription': 'These autoimmune haematological diseases are rare diseases affecting the child, often very young, and serious and potentially life-threatening. International literature data are scarce, and include individual cases or small series.\n\nThey do not allow to determine an optimal therapeutic strategy in case of escape from the first-line treatments. Existing treatments (long-term corticosteroid therapy, immunoglobulins, splenectomy, immunosuppressants, chemotherapies, and more recently anti-CD20 antibodies) are inconsistently effective, and often associated with serious side effects.\n\nThe seriousness of these diseases, the therapeutic difficulties, and the absence of a targeted research project in France, led to the implementation of this study.\n\nThis study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, Evans syndromes and chronic immunological thrombocytopenic purpura of children in France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age strictly below 18 years of age at initial diagnosis\n* Affiliate child or beneficiary of a social security scheme\n* Child residing in metropolitan France\n* Diagnosis of autoimmune haemolytic anemias, Evans syndrome and / or chronic Immune thrombocytopenic purpura\n* Free, informed, written and signed consent\n\nExclusion Criteria:\n\n* Diagnosis of constitutional haemolytic anemia\n* Diagnosis of platelet constitutional disease'}, 'identificationModule': {'nctId': 'NCT04070612', 'acronym': 'BIOCEREVANCE', 'briefTitle': 'National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia', 'orgStudyIdInfo': {'id': 'CHUBX 2005/18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children with autoimmune haemolytic anemia', 'description': 'A blood sample of 2 times 2 to 5 ml additional maximum', 'interventionNames': ['Other: Blood sample']}, {'label': 'Children with Evans syndrome', 'description': 'A blood sample of 2 times 2 to 5 ml additional maximum', 'interventionNames': ['Other: Blood sample']}, {'label': 'Children with Immune thrombocytopenic purpura', 'description': 'A blood sample of 2 times 2 to 5 ml additional maximum', 'interventionNames': ['Other: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': 'A blood sample of 2 times 2 to 5 ml additional maximum', 'armGroupLabels': ['Children with Evans syndrome', 'Children with Immune thrombocytopenic purpura', 'children with autoimmune haemolytic anemia']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yves PEREL, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bordeaux University Hsopital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}