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

Centre Hospitalier de Saint-Denis

Status: Enrolling

Conditions: in Relation to Sickle Cell Disease

Treatments: Biological: Measurement of AHSP concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT06735625

0048_MEDECINE INTERNE_PEDIATRI

2023-A02784-41 (Registry Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

sickle cell patients over 15 and a half years old

Experimental group

Description:

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

Treatment:

Biological: Measurement of AHSP concentration

control patients over 15 and a half years old

Other group

Description:

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

Treatment:

Biological: Measurement of AHSP concentration

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

Experimental group

Description:

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

Treatment:

Biological: Measurement of AHSP concentration

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

Other group

Description:

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

Treatment:

Biological: Measurement of AHSP concentration