Sickle Cell DiseaseNCT04839159

Study of Biological Markers in Children With Sickle Cell Disease

A study testing Blood sampling in people with Sickle Cell Disease, run by Queen Fabiola Children's University Hospital at 3 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 6 months and older
Conditions the study is for: Sickle Cell Disease
What is being tested?: Blood sampling
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 3 sitesBelgium
Study dates: 10 May 2012to 30 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

CHU Saint Pierre
Brussels, 1000
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020
HIS - Site Etterbeek-Ixelles
Brussels, 1050

Other trials in Belgium

About this study

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

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.

Conditions: Sickle Cell Disease
Being tested: Blood sampling
Keywords: Sickle cell disease, children, thrombin generation, inflammation, cytokines, adhesion molecules, plasmatic markers, coagulation
Medical subject headings: Anemia, Sickle Cell, Inflammation, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04839159
Study group	Role	What they receive
SCD Patient	Experimental	Not described Receives: Other: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasmatic levels of IL-6 at 12 months of age
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Measured: 12 months of age

Secondary outcomes (96)

Plasmatic levels of IL-6 at 6 months of age
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of IL-6 at 2 years of age
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of IL-6 at 3 years of age
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of IL-6 at 4 years of age
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of IL-1ß at 6 months of age
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of IL-1ß at 12 months of age
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of IL-1ß at 2 years of age
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of IL-1ß at 3 years of age
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of IL-1ß at 4 years of age
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of IL-8 at 6 months of age
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of IL-8 at 12 months of age
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of IL-8 at 2 years of age
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of IL-8 at 3 years of age
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of IL-8 at 4 years of age
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of IL-10 at 6 months of age
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of IL-10 at 12 months of age
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of IL-10 at 2 years of age
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of IL-10 at 3 years of age
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of IL-10 at 4 years of age
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of IL-12 at 6 months of age
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of IL-12 at 12 months of age
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of IL-12 at 2 years of age
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of IL-12 at 3 years of age
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of IL-12 at 4 years of age
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of TNF alpha at 6 months of age
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of TNF alpha at 12 months of age
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of TNF alpha at 2 years of age
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of TNF alpha at 3 years of age
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of TNF alpha at 4 years of age
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of ICAM-1 at 6 months of age
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of ICAM-1 at 12 months of age
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of ICAM-1 at 2 years of age
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of ICAM-1 at 3 years of age
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of ICAM-1 at 4 years of age
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of VCAM-1 at 6 months of age
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of VCAM-1 at 12 months of age
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of VCAM-1 at 2 years of age
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of VCAM-1 at 3 years of age
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of VCAM-1 at 4 years of age
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic VCAM-1 levels 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
Measured: Plasmatic level of VCAM-1 after in vitro stimulation with LPS
Plasmatic levels of E-selectine at 6 months of age
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of E-selectine at 12 months of age
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of E-selectine at 2 years of age
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of E-selectine at 3 years of age
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of E-selectine at 4 years of age
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of P-selectine at 6 months of age
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of P-selectine at 12 months of age
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of P-selectine at 2 years of age
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of P-selectine at 3 years of age
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of P-selectine at 4 years of age
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 6 months of age
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 12 months of age
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 2 years of age
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 3 years of age
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 4 years of age
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment
Lag time parameter in thrombin generation assay at 6 months of age
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 6 months of age
Lag time parameter in thrombin generation assay at 12 months of age
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 12 months of age
Lag time parameter in thrombin generation assay at 2 years of age
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 2 years of age
Lag time parameter in thrombin generation assay at 3 years of age
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 3 years of age
Lag time parameter in thrombin generation assay at 4 years of age
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 4 years of age
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
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: Before the introduction of any new sickle cell disease treatment
Peak height parameter in thrombin generation assay at 6 months of age
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 6 months of age
Peak height parameter in thrombin generation assay at 12 months of age
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 12 months of age
Peak height parameter in thrombin generation assay at 2 years of age
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 2 years of age
Peak height parameter in thrombin generation assay at 3 years of age
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 3 years of age
Peak height parameter in thrombin generation assay at 4 years of age
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: 4 years of age
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
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: Before the introduction of any new sickle cell disease treatment
Time to peak parameter in thrombin generation assay at 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
Measured: 6 months of age
Time to peak parameter in thrombin generation assay at 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
Measured: 12 months of age
Time to peak parameter in thrombin generation assay at 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
Measured: 2 years of age
Time to peak parameter in thrombin generation assay at 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
Measured: 3 years of age
Time to peak parameter in thrombin generation assay at 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
Measured: 4 years of age
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
Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
Measured: Before the introduction of any new sickle cell disease treatment
Endogenous thrombin potential parameter in thrombin generation assay at 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.
Measured: 6 months of age
Endogenous thrombin potential parameter in thrombin generation assay at 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.
Measured: 12 months of age
Endogenous thrombin potential parameter in thrombin generation assay at 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.
Measured: 2 years of age
Endogenous thrombin potential parameter in thrombin generation assay at 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.
Measured: 3 years of age
Endogenous thrombin potential parameter in thrombin generation assay at 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.
Measured: 4 years of age
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
Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
Measured: before the introduction of any new sickle cell disease treatment
Plasmatic levels of Factor VIII at 6 months of age
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Measured: 6 months of age
Plasmatic levels of Factor VIII at 12 months of age
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Measured: 12 months of age
Plasmatic levels of Factor VIII at 2 years of age
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Measured: 2 years of age
Plasmatic levels of Factor VIII at 3 years of age
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Measured: 3 years of age
Plasmatic levels of Factor VIII at 4 years of age
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Measured: 4 years of age
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
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
Measured: Before the introduction of any new sickle cell disease treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 201230 Jun 2021

First posted9 Apr 2021
Study start10 May 2012
Primary completion30 Jun 2021 (estimated)
Study completion30 Jun 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04839159
Sponsor's protocol ID: P2012/SCD1
Status last verified: Apr 2021
First submitted: 11 Jul 2018
Last updated: 9 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28159390
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.
PubMed 19103861
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.
PubMed 19902523
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.
PubMed 10841686
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.
PubMed 10631276
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.
PubMed 17909076
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.
PubMed 19020327
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.
PubMed 27835777
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.
PubMed 25569375
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.
PubMed 12517810
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.
PubMed 22775554

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Clinical Study on Early Inflammatory, Cell Adhesion and Hemostatic Plasmatic Markers of Endothelial Dysfunction in Children With Sickle Cell Disease (SCD)
ClinicalTrials.gov ID: NCT04839159
Acronym / sponsor ID: P2012/SCD1
Conditions: Sickle Cell Disease
Keywords: Sickle cell disease, children, thrombin generation, inflammation, cytokines, adhesion molecules, plasmatic markers, coagulation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 41 participants (estimated)
Lead sponsor: Queen Fabiola Children's University HospitalUniversity, hospital or other
Study start: 10 May 2012 (actual)
Primary completion: 30 Jun 2021 (estimated)
Study completion: 30 Jun 2021 (estimated)
First posted: 9 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SCD Patient	Experimental	Other: Blood sampling

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood samplingBlood sampling at the age of 6 and 12 months, 2-3-4 years	Other	SCD Patient
Blood samplingBlood sampling before any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres	Other	SCD Patient

Primary outcome

Plasmatic levels of IL-6 at 12 months of age
Time frame: 12 months of age
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay

96 secondary outcomes

Plasmatic levels of IL-6 at 6 months of age
Time frame: 6 months of age
Plasmatic levels of IL-6 at 2 years of age
Time frame: 2 years of age
Plasmatic levels of IL-6 at 3 years of age
Time frame: 3 years of age
Plasmatic levels of IL-6 at 4 years of age
Time frame: 4 years of age
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
Time frame: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of IL-1ß at 6 months of age
Time frame: 6 months of age
Plasmatic levels of IL-1ß at 12 months of age
Time frame: 12 months of age
Plasmatic levels of IL-1ß at 2 years of age
Time frame: 2 years of age
Plasmatic levels of IL-1ß at 3 years of age
Time frame: 3 years of age
Plasmatic levels of IL-1ß at 4 years of age
Time frame: 4 years of age
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
Time frame: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of IL-8 at 6 months of age
Time frame: 6 months of age
Plasmatic levels of IL-8 at 12 months of age
Time frame: 12 months of age
Plasmatic levels of IL-8 at 2 years of age
Time frame: 2 years of age
Plasmatic levels of IL-8 at 3 years of age
Time frame: 3 years of age
Plasmatic levels of IL-8 at 4 years of age
Time frame: 4 years of age
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
Time frame: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of IL-10 at 6 months of age
Time frame: 6 months of age
Plasmatic levels of IL-10 at 12 months of age
Time frame: 12 months of age
Plasmatic levels of IL-10 at 2 years of age
Time frame: 2 years of age
Plasmatic levels of IL-10 at 3 years of age
Time frame: 3 years of age
Plasmatic levels of IL-10 at 4 years of age
Time frame: 4 years of age
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
Time frame: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of IL-12 at 6 months of age
Time frame: 6 months of age
Plasmatic levels of IL-12 at 12 months of age
Time frame: 12 months of age
Plasmatic levels of IL-12 at 2 years of age
Time frame: 2 years of age
Plasmatic levels of IL-12 at 3 years of age
Time frame: 3 years of age
Plasmatic levels of IL-12 at 4 years of age
Time frame: 4 years of age
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
Time frame: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of TNF alpha at 6 months of age
Time frame: 6 months of age
Plasmatic levels of TNF alpha at 12 months of age
Time frame: 12 months of age
Plasmatic levels of TNF alpha at 2 years of age
Time frame: 2 years of age
Plasmatic levels of TNF alpha at 3 years of age
Time frame: 3 years of age
Plasmatic levels of TNF alpha at 4 years of age
Time frame: 4 years of age
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
Time frame: Before the introduction of any new sickle cell disease treatment
Plasmatic levels of ICAM-1 at 6 months of age
Time frame: 6 months of age
Plasmatic levels of ICAM-1 at 12 months of age
Time frame: 12 months of age
Plasmatic levels of ICAM-1 at 2 years of age
Time frame: 2 years of age
Plasmatic levels of ICAM-1 at 3 years of age
Time frame: 3 years of age
Plasmatic levels of ICAM-1 at 4 years of age
Time frame: 4 years of age

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
Background: PubMed 28159390Ware 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.
Background: PubMed 19103861Gulbis 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.
Background: PubMed 19902523Ballas 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.
Background: PubMed 10841686Horan 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.
Background: PubMed 10631276Miller 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.
Background: PubMed 17909076Quinn 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.
Background: PubMed 19020327Gladwin 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.
Background: PubMed 27835777Charrin 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.
Background: PubMed 25569375Sarray 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.
Background: PubMed 12517810Hoppe 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.
Background: PubMed 22775554Garrido 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bushra Zucca, MD principal investigator

Queen Fabiola Children's University Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood sampling in people with Sickle Cell Disease, run by Queen Fabiola Children's University Hospital at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasmatic levels of IL-6 at 12 months of age (time frame: 12 months of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04839159, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.