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Clinical Trials/NCT04205123
NCT04205123
Recruiting
N/A

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

Erasme University Hospital1 site in 1 country200 target enrollmentOctober 20, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sickle Cell Disease
Sponsor
Erasme University Hospital
Enrollment
200
Locations
1
Primary Endpoint
Urinary Albumin
Status
Recruiting
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 20, 2014
End Date
January 1, 2025
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Erasme University Hospital
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Urinary Albumin

Time Frame: each year

Nephropathy Prevalence

Secondary Outcomes

  • Eythrocyte Deformability and Erythrocyte Agregation(each year)
  • Hp, ApoL1 and HO-1 gene(first year of inclusion)
  • Erythrocyte Microparticles(each year)

Study Sites (1)

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