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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Genetic: sickle cell syndrome

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Béatrice BG Gulbis, Phd MD; Phone Number: 3427 +32 02 555 34 27; Email: Chimie@erasme.ulb.ac.be
• Study Contact Backup: Name: Jonathan JB Brauner, Md; Phone Number: 3427 +32 02 555 34 27; Email: Jonathan.Brauner@erasme.ulb.ac.be

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Erasme hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Albumin	Nephropathy Prevalence	each year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine, Plasma and Serum aliquotes in a biobank	For additional projects	Each year

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start: October 20, 2014
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: sickle cell disease; nephropathy
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: P2014/251