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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04205123
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Sickle Cell Disease 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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : October 20, 2014
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Urinary Albumin [ Time Frame: each year ]
    Nephropathy Prevalence


Secondary Outcome Measures :
  1. Erythrocyte Microparticles [ Time Frame: each year ]
    Sickle cell Nephropathy biomarker

  2. Eythrocyte Deformability and Erythrocyte Agregation [ Time Frame: each year ]
    Sickle Cell Nephropathy Biomarker

  3. Hp, ApoL1 and HO-1 gene [ Time Frame: first year of inclusion ]
    Sickle Cell Nephropathy risk factor


Other Outcome Measures:
  1. Urine, Plasma and Serum aliquotes in a biobank [ Time Frame: Each year ]
    For additional projects


Biospecimen Retention:   Samples With DNA
Blood and Urine Samples

Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205123


Contacts
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Contact: Béatrice BG Gulbis, Phd MD +32 02 555 34 27 ext 3427 Chimie@erasme.ulb.ac.be
Contact: Jonathan JB Brauner, Md +32 02 555 34 27 ext 3427 Jonathan.Brauner@erasme.ulb.ac.be

Locations
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Belgium
Erasme Hospital Recruiting
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
More Information
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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT04205123    
Other Study ID Numbers: P2014/251
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Keywords provided by Erasme University Hospital:
sickle cell disease
nephropathy
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn