Study of Biological Markers in Children With Sickle Cell Disease
- Conditions
- Sickle Cell Disease
- Interventions
- Other: Blood sampling
- Registration Number
- NCT04839159
- Lead Sponsor
- Queen Fabiola Children's University Hospital
- Brief Summary
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.
Investigators 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.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 41
- Patient aged less than 6 months
- Sickle cell syndrome SS, Sβthal or SC confirmed by hemoglobin electrophoresis
- 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
- Congenital abnormality other than sickle cell disease except for a glucose-6-phosphate-deshydrogenase
- Prematurity
- Initiation of the following therapies before enrollment: chronic transfusion regimen or bone marrow transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SCD Patient Blood sampling -
- Primary Outcome Measures
Name Time Method Plasmatic levels of IL-6 at 12 months of age 12 months of age Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
- Secondary Outcome Measures
Name Time Method Plasmatic levels of IL-12 at 3 years of age 3 years of age Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 2 years of age 2 years of age Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-6 at 6 months of age 6 months of age Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-6 at 2 years of age 2 years of age Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 12 months of age 12 months of age Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 2 years of age 2 years of age Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 12 months of age 12 months of age Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 4 years of age 4 years of age Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 3 years of age 3 years of age Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 4 years of age 4 years of age Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 6 months of age 6 months of age Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 2 years of age 2 years of age Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 4 years of age 4 years of age Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of VCAM-1 at 3 years of age 3 years of age Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of IL-6 at 3 years of age 3 years of age Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-6 at 4 years of age 4 years of age Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 6 months of age 6 months of age Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 4 years of age 4 years of age Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 12 months of age 12 months of age Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 3 years of age 3 years of age Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 12 months of age 12 months of age Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 12 months of age 12 months of age Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 6 months of age 6 months of age Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 2 years of age 2 years of age Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 4 years of age 4 years of age Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 6 months of age 6 months of age Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 12 months of age 12 months of age Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 6 months of age 6 months of age Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of VCAM-1 at 2 years of age 2 years of age Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 3 years of age 3 years of age Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 4 years of age 4 years of age Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 2 years of age 2 years of age Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 2 years of age 2 years of age Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 3 years of age 3 years of age Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 6 months of age 6 months of age Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 3 years of age 3 years of age Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 6 months of age 6 months of age Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of VCAM-1 at 12 months of age 12 months of age Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 12 months of age 12 months of age Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of VCAM-1 at 6 months of age 6 months of age Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 12 months of age 12 months of age Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 2 years of age 2 years of age Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
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 before the introduction of any new sickle cell disease treatment Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Plasmatic levels of Factor VIII at 12 months of age 12 months of age Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Plasmatic levels of VCAM-1 at 4 years of age 4 years of age Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 2 years of age 2 years of age Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 3 years of age 3 years of age Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 4 years of age 4 years of age Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of P-selectine at 6 months of age 6 months of age Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of P-selectine at 3 years of age 3 years of age Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of P-selectine at 4 years of age 4 years of age Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 6 months of age 6 months of age Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Peak height parameter in thrombin generation assay at 2 years of age 2 years of age Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Time to peak parameter in thrombin generation assay at 12 months of age 12 months of age Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
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 Before the introduction of any new sickle cell disease treatment Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
Plasmatic levels of Factor VIII at 3 years of age 3 years of age Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Plasmatic levels of P-selectine at 12 months of age 12 months of age Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 3 years of age 3 years of age Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Lag time parameter in thrombin generation assay at 6 months of age 6 months of age Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Lag time parameter in thrombin generation assay at 12 months of age 12 months of age Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Lag time parameter in thrombin generation assay at 3 years of age 3 years of age Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Peak height parameter in thrombin generation assay at 12 months of age 12 months of age Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Peak height parameter in thrombin generation assay at 3 years of age 3 years of age Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Peak height parameter in thrombin generation assay at 4 years of age 4 years of age Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
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 Before the introduction of any new sickle cell disease treatment Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Time to peak parameter in thrombin generation assay at 6 months of age 6 months of age Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
Time to peak parameter in thrombin generation assay at 4 years of age 4 years of age Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
Endogenous thrombin potential parameter in thrombin generation assay at 2 years of age 2 years of age Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Plasmatic VCAM-1 levels after in vitro stimulation with LPS Plasmatic level of VCAM-1 after in vitro stimulation with LPS Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay after in vitro stimulation with LPS
Plasmatic levels of P-selectine at 2 years of age 2 years of age Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 4 years of age 4 years of age Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Endogenous thrombin potential parameter in thrombin generation assay at 6 months of age 6 months of age Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Lag time parameter in thrombin generation assay at 2 years of age 2 years of age Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Lag time parameter in thrombin generation assay at 4 years of age 4 years of age Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Peak height parameter in thrombin generation assay at 6 months of age 6 months of age Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Time to peak parameter in thrombin generation assay at 2 years of age 2 years of age Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
Time to peak parameter in thrombin generation assay at 3 years of age 3 years of age Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
Endogenous thrombin potential parameter in thrombin generation assay at 12 months of age 12 months of age Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Endogenous thrombin potential parameter in thrombin generation assay at 3 years of age 3 years of age Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Plasmatic levels of Factor VIII at 2 years of age 2 years of age Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Plasmatic levels of Factor VIII at 4 years of age 4 years of age Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Endogenous thrombin potential parameter in thrombin generation assay at 4 years of age 4 years of age Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Plasmatic levels of Factor VIII at 6 months of age 6 months of age Measurement of plasmatic levels of Factor VIII by flow cytometric assay
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 Before the introduction of any new sickle cell disease treatment Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Trial Locations
- Locations (3)
CHU Saint Pierre
🇧🇪Brussels, Belgium
Hôpital Universitaire Des Enfants Reine Fabiola
🇧🇪Brussels, Belgium
HIS - Site Etterbeek-Ixelles
🇧🇪Brussels, Belgium