Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- AHSP concentrations measured in patients
研究概览
简要总结
Evaluation of AHSP concentration in total blood as a biomarker in adult and pediatric sickle cell patients
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
sickle cell patients over 15 and a half years old
sickle cell patients over 15 and a half years old with SS or Sβ0 phenotype
干预措施: Measurement of AHSP concentration (Biological)
control patients over 15 and a half years old
control patients over 15 and a half years old without hemoglobin abnormalities, recruited at the hospital
干预措施: Measurement of AHSP concentration (Biological)
pediatric sickle cell patients (aged between 3 and 15 and a half years)
pediatric sickle cell patients (aged between 3 and 15 and a half years) with SS or Sβ0 phenotype
干预措施: Measurement of AHSP concentration (Biological)
pediatric control patients (aged between 3 and 15 and a half years)
pediatric control patients (aged between 3 and 15 and a half years) without hemoglobin abnormalities, recruited at the hospital
干预措施: Measurement of AHSP concentration (Biological)
结局指标
主要结局
AHSP concentrations measured in patients
时间窗: 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
次要结局
- Correlation analysis(6 MONTH)