- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03541525
Pathophysiological Explorations of Red Blood Cells (GR-Ex)
September 7, 2026 updated by: Imagine Institute
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
3750
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sandra Manceau, PhD
- Phone Number: +33171196435
- Email: sandra.manceau@aphp.fr
Study Contact Backup
- Name: Pierre Buffet, MD
- Phone Number: +33142754456
- Email: pabuffet@gmail.com
Study Locations
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-
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Cotonou, Benin
- Not yet recruiting
- CHU Hôpital de la Mère et de l'enfant Lagune
-
Contact:
- Jules Alao, Pr
- Phone Number: +229 21 30 06 56
-
Principal Investigator:
- Jules Alao, Pr
-
-
-
-
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Amiens, France
- Recruiting
- CHU Amiens-Picardie
-
Principal Investigator:
- Loic Garcon
-
Contact:
- Loic Garcon, Pr
- Phone Number: 03 22 08 70 54
- Email: Garcon.Loic@chu-amiens.fr
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Antony, France
- Recruiting
- Hôpital Privé d'Antony
-
Contact:
- Alexandre Morel, Dr
- Phone Number: 01 86 86 12 34
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Principal Investigator:
- Alexandre Morel, Dr
-
Bobigny, France
- Recruiting
- Hopital Avicenne
-
Contact:
- Nathalie Ganne, Pr
- Phone Number: 01 48 02 62 76
- Email: nathalie.ganne@aphp.fr
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Principal Investigator:
- Nathalie Ganne, Pr
-
Bordeaux, France
- Recruiting
- Hôpital Pellegrin
-
Contact:
- Alain Brisson, Pr
- Phone Number: 05 40 00 68 61
- Email: a.brisson@cbmn.u-bordeaux.fr
-
Principal Investigator:
- Alain Brisson, Pr
-
Clichy, France
- Recruiting
- Hôpital Beaujon
-
Contact:
- Camille Hego, Dr
- Phone Number: 01 40 87 51 80
- Email: camille.hego@aphp.fr
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Principal Investigator:
- Camille Hego, Dr
-
Colombes, France
- Recruiting
- Hôpital Louis Mourier
-
Contact:
- Larent Gouya, Pr
- Phone Number: 01 47 60 63 34
- Email: laurent.gouya@inserm.fr
-
Principal Investigator:
- Laurent Gouya, Pr
-
Créteil, France
- Recruiting
- Hôpital Henri Mondor
-
Contact:
- Jacques Pariat, Dr
- Phone Number: 01 49 81 26 07
- Email: jacques.pariat@aphp.fr
-
Principal Investigator:
- Jacques Pariat, Dr
-
Le Kremlin-Bicêtre, France
- Recruiting
- CHU Kremlin Bicetre
-
Contact:
- Corinne Guitton, Dr
- Phone Number: 01 45 21 77 71
- Email: corinne.guitton@aphp.fr
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Principal Investigator:
- Corinne Guitton, Dr
-
Marseille, France
- Recruiting
- Hopital de la Conception
-
Contact:
- Benoit Meunier, Dr
- Phone Number: 04 91 38 39 24
- Email: BENOIT.MEUNIER@ap-hm.fr
-
Principal Investigator:
- Benoit Meunier, Dr
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Marseille, France
- Recruiting
- Hôpital d'Enfants de la TIMONE
-
Contact:
- Isabelle Thuret, Dr
- Phone Number: 04 91 38 60 33
- Email: Isabelle.THURET@ap-hm.fr
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Principal Investigator:
- Isabelle Thuret, Dr
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Montpellier, France
- Recruiting
- Hopital Saint Eloi
-
Contact:
- Patricia Aguilar-Martinez, Pr
- Phone Number: 04 67 33 70 31
- Email: p-martinez@chu-montpellier.fr
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Principal Investigator:
- Patricia Aguilar-Martinez, Pr
-
Niort, France
- Recruiting
- CHU de Niort
-
Contact:
- Sophie Deriaz, Dr
- Phone Number: 05 49 78 35 60
- Email: sophie.deriaz@ch-niort.fr
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Principal Investigator:
- Sophie Deriaz, Dr
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Paris, France
- Recruiting
- Hopital Saint-Antoine
-
Contact:
- Vincent Jachier, Dr
- Phone Number: 01 71 97 06 31
- Email: vincent.jachiet@aphp.fr
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Principal Investigator:
- Vincent Jachier, Dr
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Paris, France
- Recruiting
- Hôpital Cochin
-
Principal Investigator:
- Frédéric Pène, Pr
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Contact:
- Frédéric Pène, Pr
- Phone Number: 01 58 41 25 21
- Email: frederic.pene@aphp.fr
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Paris, France
- Recruiting
- Hopital Saint Louis
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Contact:
- Flore Sicre de Fontbrune, Dr
- Phone Number: 01 42 49 42 67
- Email: flore.sicre-de-fontbrune@aphp.fr
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Principal Investigator:
- Flore Sicre de Fontbrune, Dr
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Paris, France
- Recruiting
- Hôpital Européen Georges-Pompidou
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Principal Investigator:
- Jean-Benoit Arlet, Pr
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Contact:
- Jean-Benoit Arlet, Pr
- Phone Number: 01 56 09 57 00
- Email: jean-benoit.arlet@aphp.fr
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Paris, France
- Recruiting
- Hôpital Armand Trousseau
-
Contact:
- Marie-Hélène Odievre, Dr
- Phone Number: 01 71 73 83 20
- Email: marie-helene.odievre@aphp.fr
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Principal Investigator:
- Marie-Hélène Odievre, Dr
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Paris, France
- Recruiting
- Hopital Necker - Enfants Malades
-
Principal Investigator:
- Olivier Hermine, Pr
-
Contact:
- Olivier Hermine, Pr
- Phone Number: + 33 1 44 49 54 16
- Email: oliver.hermine@aphp.fr
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Paris, France
- Not yet recruiting
- Hôpital Robert Debré
-
Contact:
- Bérengère Koehl, Pr
- Phone Number: 01 40 03 24 22
- Email: berengere.koehl@aphp.fr
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Principal Investigator:
- Bérengère Koehl, Pr
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Paris, France
- Recruiting
- Groupe Hospitalier Diaconesses Croix Saint Simon
-
Contact:
- Wladimir Mauhin, Dr
- Phone Number: 01 44 64 16 00
- Email: WMauhin@hopital-dcss.org
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Principal Investigator:
- Wladimir Mauhin, Dr
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Paris, France
- Recruiting
- Institut Pasteur
-
Contact:
- Fabien Taieb, Dr
- Phone Number: 06 07 32 35 72
- Email: fabien.taieb@pasteur.fr
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Principal Investigator:
- Fabien Taieb, Dr
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Rouen, France
- Recruiting
- CHU de Rouen
-
Contact:
- Hélène Guizouarn, Dr
- Phone Number: 02 31 06 44 88
- Email: helene.guizouarn@univ-cotedazur.fr
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Principal Investigator:
- Hélène Guizouarn, Dr
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Saint-Mandé, France
- Recruiting
- Hôpital national d'instruction des armées Bégin
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Contact:
- Sébastien Larréché, Dr
- Phone Number: 01 43 98 52 99
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Principal Investigator:
- Sébastien Larréché, Dr
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Pointe-à-Pitre, Guadeloupe
- Not yet recruiting
- CHU de la Guadeloupe
-
Contact:
- Maryse-Etienne Julan, Pr
- Phone Number: 05 90 93 46 70
- Email: maryse.etienne-julan@chu-guadeloupe.fr
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Principal Investigator:
- Maryse-Etienne Julan, Pr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Inclusion of patients affected by red blood cell disorder and their non affected relatives
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
Biological samples including blood, surgical remainder, urine,...
|
|
Non affected relatives
Biological samples of blood for all relatives.
|
Biological samples including blood, surgical remainder, urine,...
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Innovative markers of spleen fonctionality
Time Frame: 20 years
|
Retention rate (%) of red blood cells using Microsphiltration compared with non affected subjects
|
20 years
|
|
Quantification of inflammation in sickle cell disease
Time Frame: 20 years
|
Activation rate of circulating mastocytes (%)
|
20 years
|
|
Markers of post-artesunate hemolysis
Time Frame: 20 years
|
Concentration of pitted red blood cells at day 3
|
20 years
|
|
Correlation between transfusion yield and the storage of red blood cell bags
Time Frame: 20 years
|
Increasing in haemoglobin concentration at 6 hours post transfusion
|
20 years
|
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Efficiency of Phosphodiesterase inhibitor on neutrophil adhesion in Sickle cell disease
Time Frame: 20 years
|
Proportional change in adhesion rate (%) of neutrophils measured in the peripheral blood before and after treatment with phosphodiesterase inhibitors
|
20 years
|
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Quantification of mitochondria removal during erythropoiesis in SDC patients, consequences on the mature RBC
Time Frame: 20 years
|
Mitochondria rate and level of ROS in RBC measured by Flow Cytometry
|
20 years
|
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Study of iron metabolism in Diamond-Blackfan Anemia patients
Time Frame: 20 years
|
Dosage of iron metabolism parameters
|
20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Olivier Hermine, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sissoko A, Cisse A, Duverdier C, Marin M, Dumas L, Manceau S, Maitre B, Eckly A, Fricot-Monsinjon A, Roussel C, Ndour PA, Dussiot M, Dokmak S, Aussilhou B, Dembinski J, Sauvanet A, Paye F, Lesurtel M, Cros J, Wendum D, Tichit M, Hardy D, Capito C, Allali S, Buffet P. Clearance of pathogenic erythrocytes is maintained despite spleen dysfunction in children with sickle cell disease. Am J Hematol. 2024 Dec;99(12):2267-2278. doi: 10.1002/ajh.27481. Epub 2024 Sep 17.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2017
Primary Completion (Estimated)
October 15, 2037
Study Completion (Estimated)
October 15, 2037
Study Registration Dates
First Submitted
March 23, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (Actual)
May 30, 2018
Study Record Updates
Last Update Posted (Actual)
September 9, 2026
Last Update Submitted That Met QC Criteria
September 7, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- IMNIS2015-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.