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

Not Applicable

Recruiting

• Conditions: in Relation to Sickle Cell Disease
• Interventions: Biological: Measurement of AHSP concentration

• Registration Number: NCT06735625
• Lead Sponsor: Centre Hospitalier de Saint-Denis

Brief Summary

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

Detailed Description

Research involving non-interventional humans. Selection and inclusion of patients by CHSD investigators. Collection of clinical data by investigators and CHSD URC staff.

Biochemical and hematological measurements by the CHSD medical biology laboratory for "care" samples Pseudonymization of 4 mL "research" samples by the URC then fractionation of the samples by 1 mL, and storage at -80°C within the medical biology laboratory of the CHSD.

Transport of samples at -80°C to team 1 of Dr Baudin-Creuza (Créteil). Preparation of genomic DNA from a 1 mL fraction then α and β globin genotyping by Dr Pissard.

Measurement of the AHSP concentration from the other fractions. Comparison of the AHSP concentration according to the group of subjects, and with the different parameters, then correlation analysis

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Study Start: 2025-03-06
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-03-20
• Study Completion: 2027-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria for Sickle Cell Patients

1. Adults: > 15 years and 6 months
2. Pediatrics: ≥ 3 years and ≤ 15 years and 6 months
3. Known SS or Sβ0 phenotypes

Inclusion Criteria for Control Patients.

1 -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

4-Blood sample planned as part of medical care

Exclusion Criteria

1. Hemoglobin disorder other than sickle cell disease (Criteria for Sickle Cell Patients)
2. Hemoglobinopathies other than sickle cell disease (Criteria for Control Patients)
3. Transfusion less than 3 months ago
4. Chronic active viral disease: hepatitis B, C, HIV
5. Current infections or known inflammatory pathologies
6. Known hyper or hypothyroidism or subject treated with levothyroxine
7. Active tumor pathology or remission for less than 5 years
8. Oral corticosteroid therapy in progress
9. Participation in interventional biomedical research
10. 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.
11. Non-affiliation to a social security system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sickle cell patients over 15 and a half years old	Measurement of AHSP concentration	sickle cell patients over 15 and a half years old with SS or Sβ0 phenotype
control patients over 15 and a half years old	Measurement of AHSP concentration	control patients over 15 and a half years old without hemoglobin abnormalities, recruited at the hospital
pediatric sickle cell patients (aged between 3 and 15 and a half years)	Measurement of AHSP concentration	pediatric sickle cell patients (aged between 3 and 15 and a half years) with SS or Sβ0 phenotype
pediatric control patients (aged between 3 and 15 and a half years)	Measurement of AHSP concentration	pediatric control patients (aged between 3 and 15 and a half years) without hemoglobin abnormalities, recruited at the hospital

Primary Outcome Measures

Name	Time	Method
AHSP concentrations measured in patients	6 MONTH	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

Secondary Outcome Measures

Name	Time	Method
Correlation analysis	6 MONTH	Correlation analysis between the AHSP parameter and the clinical-biological, therapeutic, and genetic parameters of adult and pediatric sickle cell patients.

Trial Locations

Locations (1)

Centre Hospitalier de Saint-Denis; 🇫🇷 Saint-Denis, France