Evaluating AHSP as a biomarker for sickle cell disease
Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"
This study is testing if the levels of a protein called AHSP in the blood can help doctors better understand and manage sickle cell disease in both adults and children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Saint-Denis Academic / other |
| Locations | 1 site (Saint-Denis) |
| Trial ID | NCT06735625 on ClinicalTrials.gov |
What this trial studies
This study evaluates the concentration of AHSP in blood samples from both adult and pediatric patients with sickle cell disease. It involves the collection of clinical data and blood samples, which are then analyzed for biochemical and hematological measurements. The study aims to correlate AHSP levels with various patient parameters to assess its potential as a biomarker for sickle cell disease. The research is conducted by a team of investigators at the Centre Hospitalier de Saint-Denis and involves collaboration with Inserm U955.
Who should consider this trial
Good fit: Ideal candidates include adults and children aged 3 years and older with known SS or Sβ0 phenotypes.
Not a fit: Patients with hemoglobin disorders other than sickle cell disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for better diagnosis and management of sickle cell disease.
How similar studies have performed: While the approach of using AHSP as a biomarker is novel, similar studies have shown promise in identifying biomarkers for sickle cell disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria for Sickle Cell Patients 1. Adults: \> 15 years and 6 months 2. Pediatrics: ≥ 3 years and ≤ 15 years and 6 months 3. 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: 1. Hemoglobin disorder other than sickle cell disease (Criteria for Sickle Cell Patients) 2. Hemoglobinopathies other than sickle cell disease (Criteria for Control Patients) 3. Transfusion less than 3 months ago 4. Chronic active viral disease: hepatitis B, C, HIV 5. Current infections or known inflammatory pathologies 6. Known hyper or hypothyroidism or subject treated with levothyroxine 7. Active tumor pathology or remission for less than 5 years 8. Oral corticosteroid therapy in progress 9. Participation in interventional biomedical research 10. 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. 11. Non-affiliation to a social security system
Where this trial is running
Saint-Denis
- Centre Hospitalier de Saint-Denis — Saint-Denis, France (Recruiting)
Study contacts
- Study coordinator: Stéphanie NGO, Coordinating Investigator
- Email: stephanie.ngo@ch-stdenis.fr
- Phone: stephanie.ngo@ch-stdenis.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.