We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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
Information provided by (Responsible Party):
Erasme University Hospital

Tracking Information
First Submitted Date October 8, 2014
First Posted Date December 19, 2019
Last Update Posted Date December 19, 2019
Study Start Date October 20, 2014
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2019)
Urinary Albumin [ Time Frame: each year ]
Nephropathy Prevalence
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 17, 2019)
  • Erythrocyte Microparticles [ Time Frame: each year ]
    Sickle cell Nephropathy biomarker
  • Eythrocyte Deformability and Erythrocyte Agregation [ Time Frame: each year ]
    Sickle Cell Nephropathy Biomarker
  • Hp, ApoL1 and HO-1 gene [ Time Frame: first year of inclusion ]
    Sickle Cell Nephropathy risk factor
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 17, 2019)
Urine, Plasma and Serum aliquotes in a biobank [ Time Frame: Each year ]
For additional projects
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease
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
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Blood and Urine Samples
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.
Condition 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.

Study Groups/Cohorts sickle cell syndrome
Inclusions of sickle cell patients aged over 17 years followed regularly in the participating centers.
Intervention: Genetic: sickle cell syndrome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 17, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: All
Ages 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
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
Listed Location Countries Belgium
Removed Location Countries  
Administrative Information
NCT Number NCT04205123
Other Study ID Numbers P2014/251
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Erasme University Hospital
Original Responsible Party Same as current
Current Study Sponsor Erasme University Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Erasme University Hospital
Verification Date December 2019