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Study of Biological Markers in Children With Sickle Cell Disease

Prospective Clinical Study on Early Inflammatory, Cell Adhesion and Hemostatic Plasmatic Markers of Endothelial Dysfunction in Children With Sickle Cell Disease (SCD)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04839159
Enrollment
41
Registered
2021-04-09
Start date
2012-05-10
Completion date
2021-06-30
Last updated
2021-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease, children, thrombin generation, inflammation, cytokines, adhesion molecules, plasmatic markers, coagulation

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. .

Interventions

OTHERBlood sampling

Blood sampling at the age of 6 and 12 months, 2-3-4 years

Sponsors

Queen Fabiola Children's University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Plasmatic levels of IL-6 at 12 months of age12 months of ageMeasurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay

Secondary

MeasureTime frameDescription
Plasmatic levels of IL-10 at 12 months of age12 months of ageMeasurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of VCAM-1 at 12 months of age12 months of ageMeasurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of IL-6 at 6 months of age6 months of ageMeasurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-6 at 2 years of age2 years of ageMeasurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-6 at 3 years of age3 years of ageMeasurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-6 at 4 years of age4 years of ageMeasurement of plasmatic levels of IL-6 (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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 6 months of age6 months of ageMeasurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 12 months of age12 months of ageMeasurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 2 years of age2 years of ageMeasurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 3 years of age3 years of ageMeasurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-1ß at 4 years of age4 years of ageMeasurement of plasmatic levels of IL-1ß (fg/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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 6 months of age6 months of ageMeasurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 12 months of age12 months of ageMeasurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 2 years of age2 years of ageMeasurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 3 years of age3 years of ageMeasurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-8 at 4 years of age4 years of ageMeasurement of plasmatic levels of IL-8 (fg/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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 6 months of age6 months of ageMeasurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 2 years of age2 years of ageMeasurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 3 years of age3 years of ageMeasurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-10 at 4 years of age4 years of ageMeasurement of plasmatic levels of IL-10 (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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 6 months of age6 months of ageMeasurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 12 months of age12 months of ageMeasurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 2 years of age2 years of ageMeasurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 3 years of age3 years of ageMeasurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of IL-12 at 4 years of age4 years of ageMeasurement 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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 6 months of age6 months of ageMeasurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 12 months of age12 months of ageMeasurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 2 years of age2 years of ageMeasurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 3 years of age3 years of ageMeasurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of TNF alpha at 4 years of age4 years of ageMeasurement 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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 6 months of age6 months of ageMeasurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 12 months of age12 months of ageMeasurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 2 years of age2 years of ageMeasurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 3 years of age3 years of ageMeasurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of ICAM-1 at 4 years of age4 years of ageMeasurement of plasmatic levels of ICAM-1 (pg/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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of VCAM-1 at 6 months of age6 months of ageMeasurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of VCAM-1 at 3 years of age3 years of ageMeasurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic levels of VCAM-1 at 4 years of age4 years of ageMeasurement of plasmatic levels of VCAM-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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Plasmatic VCAM-1 levels after in vitro stimulation with LPSPlasmatic level of VCAM-1 after in vitro stimulation with LPSMeasurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay after in vitro stimulation with LPS
Plasmatic levels of E-selectine at 6 months of age6 months of ageMeasurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 12 months of age12 months of ageMeasurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 2 years of age2 years of ageMeasurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 3 years of age3 years of ageMeasurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of E-selectine at 4 years of age4 years of ageMeasurement 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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of P-selectine at 6 months of age6 months of ageMeasurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of P-selectine at 12 months of age12 months of ageMeasurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of P-selectine at 2 years of age2 years of ageMeasurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of P-selectine at 3 years of age3 years of ageMeasurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of P-selectine at 4 years of age4 years of ageMeasurement of plasmatic levels of P-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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 6 months of age6 months of ageMeasurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 12 months of age12 months of ageMeasurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 2 years of age2 years of ageMeasurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 3 years of age3 years of ageMeasurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 4 years of age4 years of ageMeasurement 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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Lag time parameter in thrombin generation assay at 6 months of age6 months of ageMeasurement 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 age12 months of ageMeasurement 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 2 years of age2 years of ageMeasurement 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 age3 years of ageMeasurement 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 age4 years of ageMeasurement 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 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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement 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 age6 months of ageMeasurement 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 12 months of age12 months of ageMeasurement 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 2 years of age2 years of ageMeasurement 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 age3 years of ageMeasurement 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 age4 years of ageMeasurement 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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement 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 age6 months of ageMeasurement 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 12 months of age12 months of ageMeasurement 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 2 years of age2 years of ageMeasurement 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 age3 years of ageMeasurement 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 age4 years of ageMeasurement 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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
Plasmatic levels of VCAM-1 at 2 years of age2 years of ageMeasurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Endogenous thrombin potential parameter in thrombin generation assay at 12 months of age12 months of ageMeasurement 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 2 years of age2 years of ageMeasurement 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 age3 years of ageMeasurement 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 4 years of age4 years of ageMeasurement 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 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 adheresbefore the introduction of any new sickle cell disease treatmentMeasurement 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 age6 months of ageMeasurement of plasmatic levels of Factor VIII by flow cytometric assay
Plasmatic levels of Factor VIII at 12 months of age12 months of ageMeasurement of plasmatic levels of Factor VIII by flow cytometric assay
Plasmatic levels of Factor VIII at 2 years of age2 years of ageMeasurement of plasmatic levels of Factor VIII by flow cytometric assay
Plasmatic levels of Factor VIII at 3 years of age3 years of ageMeasurement of plasmatic levels of Factor VIII by flow cytometric assay
Plasmatic levels of Factor VIII at 4 years of age4 years of ageMeasurement 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 adheresBefore the introduction of any new sickle cell disease treatmentMeasurement of plasmatic levels of Factor VIII by flow cytometric assay
Endogenous thrombin potential parameter in thrombin generation assay at 6 months of age6 months of ageMeasurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026