Clinical trial NCT06735625: Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"
Official title: Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: in Relation to Sickle Cell Disease
Keywords: AHSP
Sickle Cell Disease
SS Phenotype
Sβ0 Phenotype
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
Collaborators: name: Inserm U955
First posted: 2024-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: AHSP concentrations measured in patients
timeFrame: 6 MONTH
Secondary outcomes:
measure: Correlation analysis
timeFrame: 6 MONTH
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hospitalier de Saint-Denis
Study officials:
References: