Clinical trial NCT04205123: Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sickle Cell Disease
Keywords: sickle cell disease
nephropathy
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will characterize the population of sickle cell patients 17 years and older , followed by Belgium and the Nord-Pas -De- Calais, and in the study through the signing of an inform consent.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Urinary Albumin
timeFrame: each year
Secondary outcomes:
measure: Erythrocyte Microparticles
timeFrame: each year
measure: Eythrocyte Deformability and Erythrocyte Agregation
timeFrame: each year
measure: Hp, ApoL1 and HO-1 gene
timeFrame: first year of inclusion
Other outcomes:
measure: Urine, Plasma and Serum aliquotes in a biobank
timeFrame: Each year
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
References: