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

NCT04205123 | Unknown

• 1 other identifier: P2014/251
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; nephropathy

Outcome Measures

Primary Outcomes (1)

• Urinary Albumin

  Nephropathy Prevalence

  each year

Secondary Outcomes (3)

• Erythrocyte Microparticles

  each year

• Eythrocyte Deformability and Erythrocyte Agregation

  each year

• Hp, ApoL1 and HO-1 gene

  first year of inclusion

Other Outcomes (1)

• Urine, Plasma and Serum aliquotes in a biobank

  Each year

Study Arms (1)

sickle cell syndrome

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

Genetic: sickle cell syndrome

Interventions

sickle cell syndrome 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.

sickle cell syndrome

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Urine Samples

MeSH Terms

Conditions

Anemia, Sickle Cell; Kidney Diseases

Interventions

Hemoglobin, Sickle

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hemoglobins, Abnormal; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins

Central Study Contacts

Béatrice BG Gulbis, Phd MD

CONTACT

+32 02 555 34 27; Chimie@erasme.ulb.ac.be

Jonathan JB Brauner, Md

CONTACT

+32 02 555 34 27; Jonathan.Brauner@erasme.ulb.ac.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: December 19, 2019
• Study Start: October 20, 2014
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

BE (1)