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NCT Number: NCT06735625

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

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

Recruiting

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Key information

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Saint-Denis

Saint-Denis, 93200, France

Location status: Recruiting

Location contact

Stéphanie NGO

CONTACT

[email protected]

0142356140

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of AHSP concentration

Biological

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 outcomes

  1. AHSP concentrations measured in patients

    Time frame: 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

Secondary outcomes

  1. Correlation analysis

    Time frame: 6 MONTH

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

Study contacts

Contact information is provided by the study sponsor or research team.

Stéhanie COSSEC, Project Coordinator

CONTACT

[email protected]

[email protected] ext. 01.42.35.61.40

Stéphanie NGO, Coordinating Investigator

CONTACT

[email protected]

[email protected] ext. 01 42 35 60

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Denis

Other

Collaborators

  • Inserm U955

Registry information

Acronym: AHSPDREP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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