Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT04839159
Status:
UNKNOWN
Last Update Posted:
2021-04-09
First Post:
2018-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Biological Markers in Children With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasmatic levels of IL-6 at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay'}], 'secondaryOutcomes': [{'measure': 'Plasmatic levels of IL-6 at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-6 at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-6 at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-6 at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-6 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-1ß at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-1ß at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-1ß at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-1ß at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-1ß at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-1ß before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-8 at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-8 at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-8 at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-8 at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-8 at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-8 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-10 at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-10 at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-10 at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-10 at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-10 at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-10 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-12 at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-12 at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-12 at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-12 at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-12 at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of IL-12 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of TNF alpha at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of TNF alpha at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of TNF alpha at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of TNF alpha at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of TNF alpha at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of TNF alpha before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of ICAM-1 at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of ICAM-1 at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of ICAM-1 at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of ICAM-1 at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of ICAM-1 at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of ICAM-1 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of VCAM-1 at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of VCAM-1 at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of VCAM-1 at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of VCAM-1 at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of VCAM-1 at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of VCAM-1 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic VCAM-1 levels after in vitro stimulation with LPS', 'timeFrame': 'Plasmatic level of VCAM-1 after in vitro stimulation with LPS', 'description': 'Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay after in vitro stimulation with LPS'}, {'measure': 'Plasmatic levels of E-selectine at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of E-selectine at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of E-selectine at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of E-selectine at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of E-selectine at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of E-selectine before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of P-selectine at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of P-selectine at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of P-selectine at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of P-selectine at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of P-selectine at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of P-selectine before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay'}, {'measure': 'Plasmatic levels of VEGF before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay'}, {'measure': 'Lag time parameter in thrombin generation assay at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Lag time parameter in thrombin generation assay at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Lag time parameter in thrombin generation assay at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Lag time parameter in thrombin generation assay at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Lag time parameter in thrombin generation assay at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Lag time parameter in thrombin generation assay before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Peak height parameter in thrombin generation assay at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Peak height parameter in thrombin generation assay at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Peak height parameter in thrombin generation assay at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Peak height parameter in thrombin generation assay at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Peak height parameter in thrombin generation assay at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Peak height parameter in thrombin generation assay before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Time to peak parameter in thrombin generation assay at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method'}, {'measure': 'Time to peak parameter in thrombin generation assay at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method'}, {'measure': 'Time to peak parameter in thrombin generation assay at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method'}, {'measure': 'Time to peak parameter in thrombin generation assay at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method'}, {'measure': 'Time to peak parameter in thrombin generation assay at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method'}, {'measure': 'Time to peak parameter in thrombin generation assay before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method'}, {'measure': 'Endogenous thrombin potential parameter in thrombin generation assay at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Endogenous thrombin potential parameter in thrombin generation assay at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Endogenous thrombin potential parameter in thrombin generation assay at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Endogenous thrombin potential parameter in thrombin generation assay at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Endogenous thrombin potential parameter in thrombin generation assay at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Endogenous thrombin potential parameter in thrombin generation assay before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.'}, {'measure': 'Plasmatic levels of Factor VIII at 6 months of age', 'timeFrame': '6 months of age', 'description': 'Measurement of plasmatic levels of Factor VIII by flow cytometric assay'}, {'measure': 'Plasmatic levels of Factor VIII at 12 months of age', 'timeFrame': '12 months of age', 'description': 'Measurement of plasmatic levels of Factor VIII by flow cytometric assay'}, {'measure': 'Plasmatic levels of Factor VIII at 2 years of age', 'timeFrame': '2 years of age', 'description': 'Measurement of plasmatic levels of Factor VIII by flow cytometric assay'}, {'measure': 'Plasmatic levels of Factor VIII at 3 years of age', 'timeFrame': '3 years of age', 'description': 'Measurement of plasmatic levels of Factor VIII by flow cytometric assay'}, {'measure': 'Plasmatic levels of Factor VIII at 4 years of age', 'timeFrame': '4 years of age', 'description': 'Measurement of plasmatic levels of Factor VIII by flow cytometric assay'}, {'measure': 'Plasmatic levels of Factor VIII before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'timeFrame': 'Before the introduction of any new sickle cell disease treatment', 'description': 'Measurement of plasmatic levels of Factor VIII by flow cytometric assay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle cell disease, children, thrombin generation, inflammation, cytokines, adhesion molecules, plasmatic markers, coagulation'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '28159390', 'type': 'BACKGROUND', 'citation': 'Ware RE, de Montalembert M, Tshilolo L, Abboud MR. Sickle cell disease. Lancet. 2017 Jul 15;390(10091):311-323. doi: 10.1016/S0140-6736(17)30193-9. Epub 2017 Feb 1.'}, {'pmid': '19103861', 'type': 'BACKGROUND', 'citation': 'Gulbis B, Cotton F, Ferster A, Ketelslegers O, Dresse MF, Ronge-Collard E, Minon JM, Le PQ, Vertongen F. Neonatal haemoglobinopathy screening in Belgium. J Clin Pathol. 2009 Jan;62(1):49-52. doi: 10.1136/jcp.2008.060517.'}, {'pmid': '19902523', 'type': 'BACKGROUND', 'citation': 'Ballas SK, Lieff S, Benjamin LJ, Dampier CD, Heeney MM, Hoppe C, Johnson CS, Rogers ZR, Smith-Whitley K, Wang WC, Telen MJ; Investigators, Comprehensive Sickle Cell Centers. Definitions of the phenotypic manifestations of sickle cell disease. Am J Hematol. 2010 Jan;85(1):6-13. doi: 10.1002/ajh.21550.'}, {'pmid': '10841686', 'type': 'BACKGROUND', 'citation': 'Horan J, Lerner N. Prediction of adverse outcomes in children with sickle cell disease. N Engl J Med. 2000 May 25;342(21):1612-3. doi: 10.1056/NEJM200005253422114. No abstract available.'}, {'pmid': '10631276', 'type': 'BACKGROUND', 'citation': 'Miller ST, Sleeper LA, Pegelow CH, Enos LE, Wang WC, Weiner SJ, Wethers DL, Smith J, Kinney TR. Prediction of adverse outcomes in children with sickle cell disease. N Engl J Med. 2000 Jan 13;342(2):83-9. doi: 10.1056/NEJM200001133420203.'}, {'pmid': '17909076', 'type': 'BACKGROUND', 'citation': 'Quinn CT, Lee NJ, Shull EP, Ahmad N, Rogers ZR, Buchanan GR. Prediction of adverse outcomes in children with sickle cell anemia: a study of the Dallas Newborn Cohort. Blood. 2008 Jan 15;111(2):544-8. doi: 10.1182/blood-2007-07-100719. Epub 2007 Oct 1.'}, {'pmid': '19020327', 'type': 'BACKGROUND', 'citation': 'Gladwin MT, Vichinsky E. Pulmonary complications of sickle cell disease. N Engl J Med. 2008 Nov 20;359(21):2254-65. doi: 10.1056/NEJMra0804411. No abstract available.'}, {'pmid': '27835777', 'type': 'BACKGROUND', 'citation': 'Charrin E, Ofori-Acquah SF, Nader E, Skinner S, Connes P, Pialoux V, Joly P, Martin C. Inflammatory and oxidative stress phenotypes in transgenic sickle cell mice. Blood Cells Mol Dis. 2016 Nov;62:13-21. doi: 10.1016/j.bcmd.2016.10.020. Epub 2016 Oct 28.'}, {'pmid': '25569375', 'type': 'BACKGROUND', 'citation': 'Sarray S, Saleh LR, Lisa Saldanha F, Al-Habboubi HH, Mahdi N, Almawi WY. Serum IL-6, IL-10, and TNFalpha levels in pediatric sickle cell disease patients during vasoocclusive crisis and steady state condition. Cytokine. 2015 Mar;72(1):43-7. doi: 10.1016/j.cyto.2014.11.030. Epub 2015 Jan 5.'}, {'pmid': '12517810', 'type': 'BACKGROUND', 'citation': 'Hoppe C, Klitz W, Noble J, Vigil L, Vichinsky E, Styles L. Distinct HLA associations by stroke subtype in children with sickle cell anemia. Blood. 2003 Apr 1;101(7):2865-9. doi: 10.1182/blood-2002-09-2791. Epub 2002 Nov 27.'}, {'pmid': '22775554', 'type': 'BACKGROUND', 'citation': 'Garrido VT, Proenca-Ferreira R, Dominical VM, Traina F, Bezerra MA, de Mello MR, Colella MP, Araujo AS, Saad ST, Costa FF, Conran N. Elevated plasma levels and platelet-associated expression of the pro-thrombotic and pro-inflammatory protein, TNFSF14 (LIGHT), in sickle cell disease. Br J Haematol. 2012 Sep;158(6):788-97. doi: 10.1111/j.1365-2141.2012.09218.x. Epub 2012 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'Sickle cell disease is associated with significant morbi-mortality hence the interest in an early and targeted care. At present, there is no plasmatic marker able to identify infants at higher risk of developping severe complications later in life. However, recent studies have demonstrated a correlation between certain complications of the disease and biomarkers of the endothelial dysfunction characterizing it.\n\nInvestigators prospectively followed a cohort of children diagnosed with SCD through the universal neonatal screening using inflammatory and haemostatic plasmatic markers to study their annual evolution. Investigators then will evaluate potential associations between these biological markers and the occurrence of SCD related complications. A secondary objective of this study is to evaluate the repercussions of therapeutic intervention on these markers.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged less than 6 months\n* Sickle cell syndrome SS, Sβthal or SC confirmed by hemoglobin electrophoresis\n* Subjects legal representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to let participate their child in the study\n\nExclusion Criteria:\n\n* Congenital abnormality other than sickle cell disease except for a glucose-6-phosphate-deshydrogenase\n* Prematurity\n* Initiation of the following therapies before enrollment: chronic transfusion regimen or bone marrow transplantation'}, 'identificationModule': {'nctId': 'NCT04839159', 'briefTitle': 'Study of Biological Markers in Children With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': "Queen Fabiola Children's University Hospital"}, 'officialTitle': 'Prospective Clinical Study on Early Inflammatory, Cell Adhesion and Hemostatic Plasmatic Markers of Endothelial Dysfunction in Children With Sickle Cell Disease (SCD)', 'orgStudyIdInfo': {'id': 'P2012/SCD1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCD Patient', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Blood sampling at the age of 6 and 12 months, 2-3-4 years', 'armGroupLabels': ['SCD Patient']}, {'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Blood sampling before any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres', 'armGroupLabels': ['SCD Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Universitaire Des Enfants Reine Fabiola', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1050', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'HIS - Site Etterbeek-Ixelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Bushra Zucca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen Fabiola Children's University Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen Fabiola Children's University Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}