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

NCT ID: NCT04205123

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-20

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Sickle Cell Disease

Keywords

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sickle cell disease nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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sickle cell syndrome

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

sickle cell syndrome

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erasme Hospital

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Béatrice BG Gulbis, Phd MD

Role: CONTACT

Phone: +32 02 555 34 27

Email: [email protected]

Jonathan JB Brauner, Md

Role: CONTACT

Phone: +32 02 555 34 27

Email: [email protected]

Other Identifiers

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P2014/251

Identifier Type: -

Identifier Source: org_study_id