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

Conditionin Relation to Sickle Cell Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3+

SponsorCentre Hospitalier de Saint-Denis

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults: > 15 years and 6 months

Pediatrics: ≥ 3 years and ≤ 15 years and 6 months

Known SS or Sβ0 phenotypes

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Measurement of AHSP concentration
Biological/Vaccine
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.

Treatment groups

100 Participants

are divided into 4 treatment groups

Group A: sickle cell patients over 15 and a half years oldExperimental treatment 1 intervention

Group B: control patients over 15 and a half years oldOther 1 intervention

Group C: pediatric sickle cell patients (aged between 3 and 15 and a half years)Experimental treatment 1 intervention

Group D: pediatric control patients (aged between 3 and 15 and a half years)Other 1 intervention

Trial outcomes

Primary outcomes

AHSP concentrations measured in patients

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

Time frame

6 MONTH

Secondary outcomes

Correlation analysis

Correlation analysis between the AHSP parameter and the clinical-biological, therapeutic, and genetic parameters of adult and pediatric sickle cell patients.

Time frame

6 MONTH

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier de Saint-Denis

Lead sponsor

Inserm U955

Collaborator

Source ClinicalTrials.gov

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