Red Blood Cell DisorderGR-ExNCT03541525
Pathophysiological Explorations of Red Blood Cells
An observational study of Red Blood Cell Disorder, run by Imagine Institute at 25 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Red Blood Cell Disorder
- What is being tested?
- Biological sampling
- How many people
- 3,750 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 16 Oct 2017to 15 Oct 2037
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Inclusion of patients affected by red blood cell disorder and their non affected relatives
Who may be able to join
- 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.
Who cannot join
- Being deprived of freedom
Trial locations and contacts
25 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 3 countries
France23 sites, 23 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens
Loic Garcon, Pr, 03 22 08 70 54, Garcon.Loic@chu-amiens.fr
Loic Garcon
- Recruiting
Hôpital Privé d'Antony
Antony
Alexandre Morel, Dr, 01 86 86 12 34
Alexandre Morel, Dr
- Recruiting
Hôpital Avicenne
Bobigny
Nathalie Ganne, Pr, 01 48 02 62 76, nathalie.ganne@aphp.fr
Nathalie Ganne, Pr
- Recruiting
Hôpital Pellegrin
Bordeaux
Alain Brisson, Pr, 05 40 00 68 61, a.brisson@cbmn.u-bordeaux.fr
Alain Brisson, Pr
- Recruiting
Hôpital Beaujon
Clichy
Camille Hego, Dr, 01 40 87 51 80, camille.hego@aphp.fr
Camille Hego, Dr
- Recruiting
Hôpital Louis Mourier
Colombes
Larent Gouya, Pr, 01 47 60 63 34, laurent.gouya@inserm.fr
Laurent Gouya, Pr
- Recruiting
Hopital Henri Mondor
Créteil
Jacques Pariat, Dr, 01 49 81 26 07, jacques.pariat@aphp.fr
Jacques Pariat, Dr
- Recruiting
CHU Kremlin Bicetre
Le Kremlin-Bicêtre
Corinne Guitton, Dr, 01 45 21 77 71, corinne.guitton@aphp.fr
Corinne Guitton, Dr
- Recruiting
Hopital de la conception
Marseille
Benoit Meunier, Dr, 04 91 38 39 24, BENOIT.MEUNIER@ap-hm.fr
Benoit Meunier, Dr
- Recruiting
Hôpital d'Enfants de la TIMONE
Marseille
Isabelle Thuret, Dr, 04 91 38 60 33, Isabelle.THURET@ap-hm.fr
Isabelle Thuret, Dr
- Recruiting
Hôpital Saint Eloi
Montpellier
Patricia Aguilar-Martinez, Pr, 04 67 33 70 31, p-martinez@chu-montpellier.fr
Patricia Aguilar-Martinez, Pr
- Recruiting
CHU de Niort
Niort
Sophie Deriaz, Dr, 05 49 78 35 60, sophie.deriaz@ch-niort.fr
Sophie Deriaz, Dr
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris
Wladimir Mauhin, Dr, 01 44 64 16 00, WMauhin@hopital-dcss.org
Wladimir Mauhin, Dr
- Recruiting
Hopital Necker - Enfants malades
Paris
Olivier Hermine, Pr, + 33 1 44 49 54 16, oliver.hermine@aphp.fr
Olivier Hermine, Pr
- Recruiting
Hôpital Armand Trousseau
Paris
Marie-Hélène Odievre, Dr, 01 71 73 83 20, marie-helene.odievre@aphp.fr
Marie-Hélène Odievre, Dr
- Recruiting
Hôpital Cochin
Paris
Frédéric Pène, Pr, 01 58 41 25 21, frederic.pene@aphp.fr
Frédéric Pène, Pr
- Recruiting
Hôpital Européen Georges-Pompidou
Paris
Jean-Benoit Arlet, Pr, 01 56 09 57 00, jean-benoit.arlet@aphp.fr
Jean-Benoit Arlet, Pr
- Not yet recruiting
Hôpital Robert Debré
Paris
Bérengère Koehl, Pr, 01 40 03 24 22, berengere.koehl@aphp.fr
Bérengère Koehl, Pr
- Recruiting
Hôpital Saint Louis
Paris
Flore Sicre de Fontbrune, Dr, 01 42 49 42 67, flore.sicre-de-fontbrune@aphp.fr
Flore Sicre de Fontbrune, Dr
- Recruiting
Hôpital Saint-Antoine
Paris
Vincent Jachier, Dr, 01 71 97 06 31, vincent.jachiet@aphp.fr
Vincent Jachier, Dr
- Recruiting
Institut Pasteur
Paris
Fabien Taieb, Dr, 06 07 32 35 72, fabien.taieb@pasteur.fr
Fabien Taieb, Dr
- Recruiting
CHU de Rouen
Rouen
Hélène Guizouarn, Dr, 02 31 06 44 88, helene.guizouarn@univ-cotedazur.fr
Hélène Guizouarn, Dr
- Recruiting
Hôpital national d'instruction des armées Bégin
Saint-Mandé
Sébastien Larréché, Dr, 01 43 98 52 99
Sébastien Larréché, Dr
Benin1 site, 1 recruiting
- Not yet recruiting
CHU Hôpital de la Mère et de l'enfant Lagune
Cotonou
Jules Alao, Pr, +229 21 30 06 56
Jules Alao, Pr
Guadeloupe1 site, 1 recruiting
- Not yet recruiting
CHU de la Guadeloupe
Pointe-à-Pitre
Maryse-Etienne Julan, Pr, 05 90 93 46 70, maryse.etienne-julan@chu-guadeloupe.fr
Maryse-Etienne Julan, Pr
About this study
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
- Being tested
- Biological sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingOther
Biological samples including blood, surgical remainder, urine,...
| Study group | Role | What they receive |
|---|---|---|
| Affected patients | Biological samples of blood for all patients. Biological samples of saliva, surgical remainder (skin, tumor, kidney,....), saliva, urine, hair. Receives: Other: Biological sampling | |
| Non affected relatives | Biological samples of blood for all relatives. Receives: Other: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Innovative markers of spleen fonctionality
Retention rate (%) of red blood cells using Microsphiltration compared with non affected subjects
Measured: 20 years
Quantification of inflammation in sickle cell disease
Activation rate of circulating mastocytes (%)
Measured: 20 years
Markers of post-artesunate hemolysis
Concentration of pitted red blood cells at day 3
Measured: 20 years
Correlation between transfusion yield and the storage of red blood cell bags
Increasing in haemoglobin concentration at 6 hours post transfusion
Measured: 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
Measured: 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
Measured: 20 years
Study of iron metabolism in Diamond-Blackfan Anemia patients
Dosage of iron metabolism parameters
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start16 Oct 2017
- Primary completion15 Oct 2037 (estimated)
- Study completion15 Oct 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Red Blood Cell DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hermine, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541525
- Sponsor's protocol ID
- IMNIS2015-04
- Acronym
- GR-Ex
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2018
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39286963Qiang 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.
PubMed 36730189
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Explorations of Red Blood Cells
- ClinicalTrials.gov ID
- NCT03541525
- Acronym / sponsor ID
- GR-Ex / IMNIS2015-04
- Conditions
- Red Blood Cell Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,750 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 15 Oct 2037 (estimated)
- Study completion
- 15 Oct 2037 (estimated)
- First posted
- 30 May 2018 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected patients | – | Other: Biological samplingBiological samples of blood for all patients. Biological samples of saliva, surgical remainder (skin, tumor, kidney,....), saliva, urine, hair. |
| Non affected relatives | – | Other: Biological samplingBiological samples of blood for all relatives. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion of patients affected by red blood cell disorder and their non affected relatives
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Being deprived of freedom
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 |
|---|---|---|
| Biological samplingBiological samples including blood, surgical remainder, urine,... | Other | Affected patients, Non affected relatives |
Primary outcome
Innovative markers of spleen fonctionality
Time frame: 20 years
Retention rate (%) of red blood cells using Microsphiltration compared with non affected subjects
Quantification of inflammation in sickle cell disease
Time frame: 20 years
Activation rate of circulating mastocytes (%)
Markers of post-artesunate hemolysis
Time frame: 20 years
Concentration of pitted red blood cells at day 3
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
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
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
Study of iron metabolism in Diamond-Blackfan Anemia patients
Time frame: 20 years
Dosage of iron metabolism parameters
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 9 Sep 2026.
- Derived from this study: PubMed 39286963Sissoko 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.
- Derived from this study: PubMed 36730189Qiang 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.
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A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
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Sickle Cell Disease (SCD)
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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.
Olivier Hermine, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Red Blood Cell Disorder, run by Imagine Institute at 25 sites in 3 countries.
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 4 inclusion and 1 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, Benin, Guadeloupe. 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 Sandra Manceau, PhD (+33171196435, sandra.manceau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Innovative markers of spleen fonctionality (time frame: 20 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03541525, which also lists 2 linked publications.
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 9 Sep 2026.