Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease

Recruiting

• Conditions: Sickle Cell Disease
• Interventions: Genetic: sickle cell syndrome

• Registration Number: NCT04205123
• Lead Sponsor: Erasme University Hospital

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).

Study Timeline

• Study First Submitted: 2014-10-08
• Study Start: 2014-10-20
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-17
• Last Update Submitted: 2019-12-17
• Study First Posted: 2019-12-19
• Last Update Posted: 2019-12-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sickle cell syndrome	sickle cell syndrome	Inclusions of sickle cell patients aged over 17 years followed regularly in the participating centers.

Primary Outcome Measures

Name	Time	Method
Urinary Albumin	each year	Nephropathy Prevalence

Secondary Outcome Measures

Name	Time	Method
Eythrocyte Deformability and Erythrocyte Agregation	each year	Sickle Cell Nephropathy Biomarker
Hp, ApoL1 and HO-1 gene	first year of inclusion	Sickle Cell Nephropathy risk factor
Erythrocyte Microparticles	each year	Sickle cell Nephropathy biomarker

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Belgium