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Pathophysiological Explorations of Red Blood Cells (GR-Ex)

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ClinicalTrials.gov Identifier: NCT03541525
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Imagine Institute

Brief 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.

Condition or disease Intervention/treatment
Red Blood Cell Disorder Other: Biological sampling

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pathophysiological Explorations of Red Blood Cells
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : October 10, 2027
Estimated Study Completion Date : October 10, 2027

Group/Cohort Intervention/treatment
Affected patients
Biological samples of blood for all patients. Biological samples of saliva, surgical remainder (skin, tumor, kidney,....), saliva, urine, hair.
Other: Biological sampling
Biological samples including blood, surgical remainder, urine,...

Non affected relatives
Biological samples of blood for all relatives.
Other: Biological sampling
Biological samples including blood, surgical remainder, urine,...




Primary Outcome Measures :
  1. Innovative markers of spleen fonctionality [ Time Frame: 10 years ]
    Retention rate (%) of red blood cells using Microsphiltration compared with non affected subjects

  2. Quantification of inflammation in sickle cell disease [ Time Frame: 10 years ]
    Activation rate of circulating mastocytes (%)

  3. Markers of post-artesunate hemolysis [ Time Frame: 10 years ]
    Concentration of pitted red blood cells at day 3

  4. Correlation between transfusion yield and the storage of red blood cell bags [ Time Frame: 10 years ]
    Increasing in haemoglobin concentration at 6 hours post transfusion

  5. Efficiency of Phosphodiesterase inhibitor on neutrophil adhesion in Sickle cell disease [ Time Frame: 10 years ]
    Proportional change in adhesion rate (%) of neutrophils measured in the peripheral blood before and after treatment with phosphodiesterase inhibitors

  6. Quantification of mitochondria removal during erythropoiesis in SDC patients, consequences on the mature RBC [ Time Frame: 10 years ]
    Mitochondria rate and level of ROS in RBC measured by Flow Cytometry

  7. Study of iron metabolism in Diamond-Blackfan Anemia patients [ Time Frame: 10 years ]
    Dosage of iron metabolism parameters


Biospecimen Retention:   Samples With DNA

Collection of:

  • Blood samples
  • Surgical remainders (tumor, skin, kidney,...)
  • Urine
  • Saliva
  • Hair


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Inclusion of patients affected by red blood cell disorder and their non affected relatives
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541525


Contacts
Contact: Joël Veiga +33142754456 veigajoel@gmail.com
Contact: Pierre Buffet, MD +33142754456 pabuffet@gmail.com

Locations
France
Hopital Necker - Enfants malades Recruiting
Paris, France
Contact: Hermine Olivier    + 33 1 44 49 54 16    oliver.hermine@aphp.fr   
Sponsors and Collaborators
Imagine Institute
Investigators
Study Director: Olivier Hermine, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Imagine Institute
ClinicalTrials.gov Identifier: NCT03541525     History of Changes
Other Study ID Numbers: IMNIS2015-04
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No