in Relation to Sickle Cell DiseaseAHSPDREPNCT06735625
Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"
A study testing Measurement of AHSP concentration in people with in Relation to Sickle Cell Disease, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
Evaluation of AHSP concentration in total blood as a biomarker in adult and pediatric sickle cell patients Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- in Relation to Sickle Cell Disease
- What is being tested?
- Measurement of AHSP concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2025to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults: > 15 years and 6 months
- Pediatrics: ≥ 3 years and ≤ 15 years and 6 months
- Known SS or Sβ0 phenotypes
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stéphanie NGO, Coordinating Investigator contact
Stéhanie COSSEC, Project Coordinator contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Denis
Saint-Denis, 93200
Stéphanie NGO, 0142356140, stephanie.ngod@ch-stdenis.fr
About this study
Evaluation of AHSP concentration in total blood as a biomarker in adult and pediatric sickle cell patients
Read the detailed description
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
- Conditions
- in Relation to Sickle Cell Disease
- Being tested
- Measurement of AHSP concentration
- Keywords
- AHSP, Sickle Cell Disease, SS Phenotype, Sβ0 Phenotype
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of AHSP concentrationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| sickle cell patients over 15 and a half years old | Experimental | sickle cell patients over 15 and a half years old with SS or Sβ0 phenotype Receives: Biological: Measurement of AHSP concentration |
| control patients over 15 and a half years old | Other | control patients over 15 and a half years old without hemoglobin abnormalities, recruited at the hospital Receives: Biological: Measurement of AHSP concentration |
| pediatric sickle cell patients (aged between 3 and 15 and a half years) | Experimental | pediatric sickle cell patients (aged between 3 and 15 and a half years) with SS or Sβ0 phenotype Receives: Biological: Measurement of AHSP concentration |
| pediatric control patients (aged between 3 and 15 and a half years) | Other | pediatric control patients (aged between 3 and 15 and a half years) without hemoglobin abnormalities, recruited at the hospital Receives: Biological: Measurement of AHSP concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 MONTH
Secondary outcomes (1)
Correlation analysis
Correlation analysis between the AHSP parameter and the clinical-biological, therapeutic, and genetic parameters of adult and pediatric sickle cell patients.
Measured: 6 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start6 Mar 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Relation to Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 30 sickle cell patients over 15 and a half years old with SS or Sβ0 phenotype 30 control patients over 15 and a half years old without hemoglobin abnormalities, recruited at the hospital 20 pediatric sickle cell patients (aged between 3 and 15 and a half years) with SS or Sβ0 phenotype 20 pediatric control patients (aged between 3 and 15 and a half years) without hemoglobin abnormalities, recruited at the hospital
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Collaborators
- Inserm U955
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735625
- Sponsor's protocol ID
- 0048_MEDECINE INTERNE_PEDIATRI
- Other IDs
- 2023-A02784-41
- Acronym
- AHSPDREP
- Status last verified
- Jul 2024
- First submitted
- 11 Dec 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"
- ClinicalTrials.gov ID
- NCT06735625
- Acronym / sponsor ID
- AHSPDREP / 0048_MEDECINE INTERNE_PEDIATRI
- Conditions
- in Relation to Sickle Cell Disease
- Keywords
- AHSP, Sickle Cell Disease, SS Phenotype, Sβ0 Phenotype
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Collaborators
- Inserm U955
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of AHSP concentration in total blood as a biomarker in adult and pediatric sickle cell patients
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 30 sickle cell patients over 15 and a half years old with SS or Sβ0 phenotype 30 control patients over 15 and a half years old without hemoglobin abnormalities, recruited at the hospital 20 pediatric sickle cell patients (aged between 3 and 15 and a half years) with SS or Sβ0 phenotype 20 pediatric control patients (aged between 3 and 15 and a half years) without hemoglobin abnormalities, recruited at the hospital
| Arm | Type | Receives |
|---|---|---|
| sickle cell patients over 15 and a half years old | Experimental | Biological: Measurement of AHSP concentrationsickle cell patients over 15 and a half years old with SS or Sβ0 phenotype |
| control patients over 15 and a half years old | Other | Biological: Measurement of AHSP concentrationcontrol patients over 15 and a half years old without hemoglobin abnormalities, recruited at the hospital |
| pediatric sickle cell patients (aged between 3 and 15 and a half years) | Experimental | Biological: Measurement of AHSP concentrationpediatric sickle cell patients (aged between 3 and 15 and a half years) with SS or Sβ0 phenotype |
| pediatric control patients (aged between 3 and 15 and a half years) | Other | Biological: Measurement of AHSP concentrationpediatric control patients (aged between 3 and 15 and a half years) without hemoglobin abnormalities, recruited at the hospital |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adults: > 15 years and 6 months
- Pediatrics: ≥ 3 years and ≤ 15 years and 6 months
- Known SS or Sβ0 phenotypes
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of AHSP concentrationPseudonymization 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. | Biological | control patients over 15 and a half years old, pediatric control patients (aged between 3 and 15 and a half years), pediatric sickle cell patients (aged between 3 and 15 and a half years), sickle cell patients over 15 and a half years old |
Primary outcome
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
1 secondary outcome
Correlation analysis
Time frame: 6 MONTH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Decreased sickle red blood cell adhesion to laminin by hydroxyurea is associated with inhibition of Lu/BCAM protein phosphorylationLink provided by the sponsor.
- F. Clinical management of adult sickle-cell disease. Curr Opin HematolLink provided by the sponsor.
- 2D DIGE based proteomics study of erythrocyte cytosol in sickle cell disease: altered proteostasis and oxidative stressLink provided by the sponsor.
- Alpha-hemoglobin stabilizing protein (AHSP), a kinetic scheme of the action of a human mutant, AHSPV56GLink provided by the sponsor.
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Recruiting
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Sickle Cell Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie NGO, Coordinating Investigator contact
Stéhanie COSSEC, Project Coordinator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of AHSP concentration in people with in Relation to Sickle Cell Disease, run by Centre Hospitalier de Saint-Denis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie NGO, Coordinating Investigator (stephanie.ngo@ch-stdenis.fr ext. 01 42 35 60, stephanie.ngo@ch-stdenis.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHSP concentrations measured in patients (time frame: 6 MONTH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.