Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT04205123|
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : December 19, 2019
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The objective of the study is to refine our knowledge on the physiopathology of the symptoms and the complications for the patients affected by a drepanocytic syndrome.
The establishment of risk factors and indicators of severity will allow to target better the patients requiring an adequate strategy in order to prevent the installation of some complications or to limit their worsening.
|Condition or disease||Intervention/treatment|
|Sickle Cell Disease||Genetic: sickle cell syndrome|
Some additional tubes will be taken during the usual control of blood test of the drepanocytic patient. A sample of urine will be also asked. Tubes, after pre-treatment, will be sent to Erasme hospital.
A series ob biological but also genetic parameters, both at asymptomatic patients and those in aigüe phase of the disease, can be measured either immediately or a little time after the prelevement.
In this way, we can study numerous domains linked to the physiopathology of the drepanocytose (hémolyse, vaso-occlusion, rheology, factors modulators of the clinical expression). The surplus of the collection could be used for other researchs. It's in this context that we also wish to constitute a biobank of serum, plasma and urine for these drepanocytic patients by surplus of taken material.
The study is realized within the framework of an academic collaboration between institutions. The bank of takings will be located in the reference center of the pathologies of the Red Blood Cell (laboratory of medical chemistry of the erasme hospital).
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Academic Multicenter Prospective Observational Study of the Factors Responsible for Nephropathy in Patients With Sickle Cell Disease Followed by Belgium and the Nord-Pas -De- Calais Region and Creating a Biobank of Blood and Urine|
|Study Start Date :||October 20, 2014|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||January 1, 2025|
sickle cell syndrome
Inclusions of sickle cell patients aged over 17 years followed regularly in the participating centers.
Genetic: sickle cell syndrome
Academic Study prospective multicenter observational factors responsible for nephropathy in patients with sickle cell disease followed by Belgium and the Nord-Pas -De- Calais Region and creating a biobank of blood and urine.
In the population of patients with SCD followed in all participating centres.
Know the prevalence of nephropathy and the relationship between it with their some of their genotypic mutations and clinical phenotype promoting mutated hemoglobin polymerization.
Determine the behaviour of dense cells in the basal state and in a hypeosmolaire environment
Determine the place of the erythrocyte microparticles as a biomarker of sickle cell nephropathy
Studying genes known as risk factor for proteinuria
Create a BioBank of samples of sickle cell patients in clinically stable condition for other research purposes.
- Urinary Albumin [ Time Frame: each year ]Nephropathy Prevalence
- Erythrocyte Microparticles [ Time Frame: each year ]Sickle cell Nephropathy biomarker
- Eythrocyte Deformability and Erythrocyte Agregation [ Time Frame: each year ]Sickle Cell Nephropathy Biomarker
- Hp, ApoL1 and HO-1 gene [ Time Frame: first year of inclusion ]Sickle Cell Nephropathy risk factor
- Urine, Plasma and Serum aliquotes in a biobank [ Time Frame: Each year ]For additional projects
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||17 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Patients 18 years or older with sickle cell syndrome
- Signing an inform consent form after validation on it by the Ethics Committees of the participating centers.
- Any pathology concomitant risk of nephropathy
- Severe CVO within the month preceding the sampling
- Transfusions within 3 months prior to sampling
- Pregnant patient or within 3 months post- accouhcement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205123
|Contact: Béatrice BG Gulbis, Phd MD||+32 02 555 34 27 ext 3427||Chimie@erasme.ulb.ac.be|
|Contact: Jonathan JB Brauner, Md||+32 02 555 34 27 ext 3427||Jonathan.Brauner@erasme.ulb.ac.be|
|Brussels, Belgium, 1070|
|Responsible Party:||Erasme University Hospital|
|Other Study ID Numbers:||
|First Posted:||December 19, 2019 Key Record Dates|
|Last Update Posted:||December 19, 2019|
|Last Verified:||December 2019|
sickle cell disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn