Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Measurement of AHSP concentration.
- Who it may be relevant to
- Registry conditions: in Relation to Sickle Cell Disease. Basic parameters: from 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Biological Measurement of AHSP concentration
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.
Primary outcome measures
- AHSP concentrations measured in patients [Time frame: 6 MONTH]
Secondary outcome measures (1)
- Correlation analysis [Time frame: 6 MONTH]
Eligibility criteria
Inclusion criteria
Inclusion Criteria for Sickle Cell Patients
- Adults: > 15 years and 6 months
- Pediatrics: ≥ 3 years and ≤ 15 years and 6 months
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Hospitalier de Saint-Denis — Saint-Denis
Identifiers
NCT: NCT06735625 · 0048_MEDECINE INTERNE_PEDIATRI · 2023-A02784-41