Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"

NCT06735625 | Recruiting DMC

• 2 other identifiers: 0048_MEDECINE INTERNE_PEDIATRI2023-A02784-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of AHSP concentration in total blood as a biomarker in adult and pediatric sickle cell patients

Conditions

in Relation to Sickle Cell Disease

Keywords

AHSP; Sickle Cell Disease; SS Phenotype; Sβ0 Phenotype

Outcome Measures

Primary Outcomes (1)

• AHSP concentrations measured in patients

  Comparison of AHSP concentrations measured in total blood between: Those of adult sickle cell patients and those of adult control patients without sickle cell disease Those of pediatric sickle cell patients and those of pediatric control patients without sickle cell disease

  6 MONTH

Secondary Outcomes (1)

• Correlation analysis

  6 MONTH

Study Arms (4)

sickle cell patients over 15 and a half years old

EXPERIMENTAL

sickle cell patients over 15 and a half years old with SS or Sβ0 phenotype

Biological: Measurement of AHSP concentration

control patients over 15 and a half years old

OTHER

control patients over 15 and a half years old without hemoglobin abnormalities, recruited at the hospital

Biological: Measurement of AHSP concentration

pediatric sickle cell patients (aged between 3 and 15 and a half years)

EXPERIMENTAL

pediatric sickle cell patients (aged between 3 and 15 and a half years) with SS or Sβ0 phenotype

Biological: Measurement of AHSP concentration

pediatric control patients (aged between 3 and 15 and a half years)

OTHER

pediatric control patients (aged between 3 and 15 and a half years) without hemoglobin abnormalities, recruited at the hospital

Biological: Measurement of AHSP concentration

Interventions

Measurement of AHSP concentration BIOLOGICAL

Pseudonymization and identification of research samples EDTA tube of 4 mL for patients over 15 and a half years old, and 2 EDTA tubes of 2 mL for children aged 3 to 15 and a half years, totaling 4 mL) by Team 4 according to the procedure in force at the URC. The 4 mL research sample will then be divided into 1 mL fractions by a technician in the laboratory and stored at -80°C in the medical biology laboratory.

control patients over 15 and a half years old; pediatric control patients (aged between 3 and 15 and a half years); pediatric sickle cell patients (aged between 3 and 15 and a half years); sickle cell patients over 15 and a half years old

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults: \> 15 years and 6 months
• Pediatrics: ≥ 3 years and ≤ 15 years and 6 months
• Known SS or Sβ0 phenotypes
• Adults: \> 15 years and 6 months /Pediatrics: ≥ 3 years and ≤ 15 years and 6 months 2-Absence of Hemoglobinopathy 3-Follow-up for one of the following conditions (adults): Evaluation of hematological disease excluding hemoglobinopathy, evaluation of prolonged fever or inflammatory syndrome, initial or episodic evaluation of an auto-inflammatory disease or systemic disease, general health deterioration
• Follow-up for one of the following conditions (pediatrics): Suspected precocious puberty, growth delay, or neurodevelopmental disorder
• Blood sample planned as part of medical care

You may not qualify if:

• Hemoglobin disorder other than sickle cell disease (Criteria for Sickle Cell Patients)
• Hemoglobinopathies other than sickle cell disease (Criteria for Control Patients)
• Transfusion less than 3 months ago
• Chronic active viral disease: hepatitis B, C, HIV
• Current infections or known inflammatory pathologies
• Known hyper or hypothyroidism or subject treated with levothyroxine
• Active tumor pathology or remission for less than 5 years
• Oral corticosteroid therapy in progress
• Participation in interventional biomedical research
• Opposition to participation in research by the patient if he is an adult, or by one of the two parents if the patient is a minor.
• Non-affiliation to a social security system

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead
• Inserm U955: collaborator

Study Sites (1)

Centre Hospitalier de Saint-Denis

Saint-Denis, 93200, France

RECRUITING

Related Links

• Decreased sickle red blood cell adhesion to laminin by hydroxyurea is associated with inhibition of Lu/BCAM protein phosphorylation
• F. Clinical management of adult sickle-cell disease. Curr Opin Hematol
• 2D DIGE based proteomics study of erythrocyte cytosol in sickle cell disease: altered proteostasis and oxidative stress
• Alpha-hemoglobin stabilizing protein (AHSP), a kinetic scheme of the action of a human mutant, AHSPV56G

MeSH Terms

Conditions

Anemia, Sickle Cell

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

Central Study Contacts

Stéphanie NGO, Coordinating Investigator

CONTACT

stephanie.ngo@ch-stdenis.fr; stephanie.ngo@ch-stdenis.fr

Stéhanie COSSEC, Project Coordinator

CONTACT

stephanie.cossec@ghtpdfr.fr; stephanie.cossec@ghtpdfr.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 30 sickle cell patients over 15 and a half years old with SS or Sβ0 phenotype 30 control patients over 15 and a half years old without hemoglobin abnormalities, recruited at the hospital 20 pediatric sickle cell patients (aged between 3 and 15 and a half years) with SS or Sβ0 phenotype 20 pediatric control patients (aged between 3 and 15 and a half years) without hemoglobin abnormalities, recruited at the hospital

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: March 6, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: April 2, 2025

Record last verified: 2024-07

Locations

FR (1)