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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03541525
Other study ID # IMNIS2015-04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 16, 2017
Est. completion date October 15, 2037

Study information

Verified date July 2023
Source Imagine Institute
Contact Sandra Manceau, PhD
Phone +33171196435
Email sandra.manceau@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

GR-Ex is a program labelled by Labex (Laboratory of Excellence) by the French Ministry of Higher Education and Research. This program aims to develop the means to improve knowledge in the physiology and pathologies of erythropoiesis, red blood cells and iron metabolism, and to develop new therapeutic protocols capable of providing added value in terms of innovation.


Recruitment information / eligibility

Status Recruiting
Enrollment 3750
Est. completion date October 15, 2037
Est. primary completion date October 15, 2037
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - To be affected or have a family history of disease bound to the red blood cell, - For adult subjects, have signed an informed consent form, - For minor or major under legal safeguard subjects, the form must be signed by both parents (for minors) or by the legal representative, - Be affiliated to health insurance. Exclusion Criteria: - Being deprived of freedom

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biological sampling
Biological samples including blood, surgical remainder, urine,...

Locations

Country Name City State
France Hopital Necker - Enfants malades Paris

Sponsors (1)

Lead Sponsor Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Innovative markers of spleen fonctionality Retention rate (%) of red blood cells using Microsphiltration compared with non affected subjects 20 years
Primary Quantification of inflammation in sickle cell disease Activation rate of circulating mastocytes (%) 20 years
Primary Markers of post-artesunate hemolysis Concentration of pitted red blood cells at day 3 20 years
Primary Correlation between transfusion yield and the storage of red blood cell bags Increasing in haemoglobin concentration at 6 hours post transfusion 20 years
Primary Efficiency of Phosphodiesterase inhibitor on neutrophil adhesion in Sickle cell disease Proportional change in adhesion rate (%) of neutrophils measured in the peripheral blood before and after treatment with phosphodiesterase inhibitors 20 years
Primary Quantification of mitochondria removal during erythropoiesis in SDC patients, consequences on the mature RBC Mitochondria rate and level of ROS in RBC measured by Flow Cytometry 20 years
Primary Study of iron metabolism in Diamond-Blackfan Anemia patients Dosage of iron metabolism parameters 20 years
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