Pathophysiological Explorations of Red Blood Cells

NCT03541525 | Recruiting

• 1 other identifier: IMNIS2015-04
• Study Type: observational
• Target: 3,750
• Locations: 3 countries
• Sites: 25

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.

Conditions

Red Blood Cell Disorder

Outcome Measures

Primary Outcomes (7)

• Innovative markers of spleen fonctionality

  Retention rate (%) of red blood cells using Microsphiltration compared with non affected subjects

  20 years

• Quantification of inflammation in sickle cell disease

  Activation rate of circulating mastocytes (%)

  20 years

• Markers of post-artesunate hemolysis

  Concentration of pitted red blood cells at day 3

  20 years

• Correlation between transfusion yield and the storage of red blood cell bags

  Increasing in haemoglobin concentration at 6 hours post transfusion

  20 years

• 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

• 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

• Study of iron metabolism in Diamond-Blackfan Anemia patients

  Dosage of iron metabolism parameters

  20 years

Study Arms (2)

Affected patients

Biological samples of blood for all patients. Biological samples of saliva, surgical remainder (skin, tumor, kidney,....), saliva, urine, hair.

Other: Biological sampling

Non affected relatives

Biological samples of blood for all relatives.

Other: Biological sampling

Interventions

Biological sampling OTHER

Biological samples including blood, surgical remainder, urine,...

Affected patients; Non affected relatives

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inclusion of patients affected by red blood cell disorder and their non affected relatives

You may qualify if:

• 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.

You may not qualify if:

• Being deprived of freedom

Sponsors & Collaborators

• Imagine Institute: lead

Study Sites (25)

CHU Hôpital de la Mère et de l'enfant Lagune

Cotonou, Benin

NOT YET RECRUITING

CHU Amiens-Picardie

Amiens, France

RECRUITING

Hôpital Privé d'Antony

Antony, France

RECRUITING

Hôpital Avicenne

Bobigny, France

RECRUITING

Hôpital Pellegrin

Bordeaux, France

RECRUITING

Hôpital Beaujon

Clichy, France

RECRUITING

Hôpital Louis Mourier

Colombes, France

RECRUITING

Hopital Henri Mondor

Créteil, France

RECRUITING

CHU Kremlin Bicetre

Le Kremlin-Bicêtre, France

RECRUITING

Hopital de la conception

Marseille, France

RECRUITING

Hôpital d'Enfants de la TIMONE

Marseille, France

RECRUITING

Hôpital Saint Eloi

Montpellier, France

RECRUITING

CHU de Niort

Niort, France

RECRUITING

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, France

RECRUITING

Hopital Necker - Enfants malades

Paris, France

RECRUITING

Hôpital Armand Trousseau

Paris, France

RECRUITING

Hôpital Cochin

Paris, France

RECRUITING

Hôpital Européen Georges-Pompidou

Paris, France

RECRUITING

Hôpital Robert Debré

Paris, France

NOT YET RECRUITING

Hôpital Saint Louis

Paris, France

RECRUITING

Hôpital Saint-Antoine

Paris, France

RECRUITING

Institut Pasteur

Paris, France

RECRUITING

CHU de Rouen

Rouen, France

RECRUITING

Hôpital national d'instruction des armées Bégin

Saint-Mandé, France

RECRUITING

CHU de la Guadeloupe

Pointe-à-Pitre, Guadeloupe

NOT YET RECRUITING

Related Publications (1)

• Qiang Y, Sissoko A, Liu ZL, Dong T, Zheng F, Kong F, Higgins JM, Karniadakis GE, Buffet PA, Suresh S, Dao M. Microfluidic study of retention and elimination of abnormal red blood cells by human spleen with implications for sickle cell disease. Proc Natl Acad Sci U S A. 2023 Feb 7;120(6):e2217607120. doi: 10.1073/pnas.2217607120. Epub 2023 Feb 2.

  PMID: 36730189 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Collection of: * Blood samples * Surgical remainders (tumor, skin, kidney,...) * Urine * Saliva * Hair

Study Officials

• Olivier Hermine, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Sandra Manceau, PhD

CONTACT

+33171196435; sandra.manceau@aphp.fr

Pierre Buffet, MD

CONTACT

+33142754456; pabuffet@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: May 30, 2018
• Study Start: October 16, 2017
• Primary Completion (Estimated): October 15, 2037
• Study Completion (Estimated): October 15, 2037
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

GU (1); BE (1); FR (23)