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

Обзор

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

Подробное описание

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

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• AHSP concentrations measured in patients [Срок оценки: 6 MONTH]

Вторичные конечные точки (1)

• Correlation analysis [Срок оценки: 6 MONTH]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Centre Hospitalier de Saint-Denis — Saint-Denis

Идентификаторы

NCT: NCT06735625 · 0048_MEDECINE INTERNE_PEDIATRI · 2023-A02784-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗