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

Sickle Cell Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04205123
• Other study ID #: P2014/251
• Status: Recruiting
• Start date: October 20, 2014
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2019
• Source: Erasme University Hospital
• Contact: Béatrice BG Gulbis, Phd MD
• Phone: +32 02 555 34 27
• Email: Chimie[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urine, Plasma and Serum aliquotes in a biobank	For additional projects	Each year
Primary	Urinary Albumin	Nephropathy Prevalence	each year
Secondary	Erythrocyte Microparticles	Sickle cell Nephropathy biomarker	each year
Secondary	Eythrocyte Deformability and Erythrocyte Agregation	Sickle Cell Nephropathy Biomarker	each year
Secondary	Hp, ApoL1 and HO-1 gene	Sickle Cell Nephropathy risk factor	first year of inclusion