Red Blood CellsERYSTREAMNCT05282888
ERYthrocyte Morphology Using Flow Imaging on ImageSTREAM Cytometer
An observational study of Red Blood Cells and Schistocytes, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Erythrocyte morphology analysis is a key step in the diagnosis flowchart of anemia. It is performed on a peripheral blood smear after May Grümwald Giemsa staining. In the context of hemolytic anemias for example, it allows the recognition of therapeutic emergencies such as sickle cell disease crisis, malaria-induced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Red Blood Cells, Schistocytes, Artificial Intelligence
- What is being tested?
- blood sample
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient for whom a blood test including a cytological evaluation of RBC morphology is performed in the routine laboratory of CHU Amiens
Who may be able to join
- Any patient for whom a blood test including a cytological evaluation of RBC morphology is performed in the routine laboratory of CHU Amiens
Who cannot join
- patients who have opposed the use of their personal data for research work
Trial locations and contacts
1 site in 1 country.
About this study
Erythrocyte morphology analysis is a key step in the diagnosis flowchart of anemia. It is performed on a peripheral blood smear after May Grümwald Giemsa staining. In the context of hemolytic anemias for example, it allows the recognition of therapeutic emergencies such as sickle cell disease crisis, malaria-induced hemolysis and thrombotic microangiopathy, the latter being characterized by the presence of schistocytes and justifying an immediate clinical care. However, cytological analysis of erythrocyte morphology requires pre-analytical interventions (smear spreading + staining), the quality of which determines the accuracy of the result. Moreover, it requires a good cytological expertise and may be sometimes subjective. For several years, alternative methods for erythrocyte morphology evaluation have been developed, based on automated hematology machines or automated microscopy. Nevertheless, none of them has yet proven itself in comparison with cytology, especially in the diagnosis of thrombotic microangiopathies. By combining the advantages of flow cytometry and microscopy, flow imaging appears to be a promising technology for the diagnosis of anemias: it does not require any pre-analytical intervention, does not require any spreading and analyzes a large number of events. Moreover, it can be coupled with artificial intelligence via the generation of an apprenticeship by the constitution of a large image data base, which then allows the recognition of the different red blood cells morphologies without human eyes. The objective of this study is to build a data base containing the main red blood cell morphologies relevant in anemia, and to validate it through a comparison in anemic patients of erythrocyte morphological assessment either directly on whole blood by flow imaging or routinely by cytological analysis of peripheral blood smear after by a trained operator.
- Conditions
- Red Blood Cells, Schistocytes, Artificial Intelligence
- Being tested
- blood sample
- Keywords
- Red blood cells, schistocytes, flow imaging, artificial intelligence
- Medical subject headings
- Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
in order to develop a diagnostic assay using an innovative technology by imaging flow cytometry to identify red blood cell morphological anomalies in the diagnosis flowchart of anemia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between classical cytological erythrocyte analysis and ImageStream flow imaging erythrocyte analysis
The investigators will characterize by flow imaging the normal and pathological erythrocyte morphologies by creating a bank of images representative of the main red blood cell abnormalities observed during anemias. The images will be classified manually by the investigators in order to create a morphological data base allowing apprenticeship via artificial intelligence. Once the database will be created, the investigators will validate it prospectively by comparison between classical cytological analysis and flow imaging on samples for which a blood test will be prescribed for anemia.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start22 Apr 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red Blood CellsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282888
- Sponsor's protocol ID
- PI2021_843_0087
- Acronym
- ERYSTREAM
- Status last verified
- Jun 2026
- First submitted
- 8 Mar 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERYthrocyte Morphology Using Flow Imaging on ImageSTREAM Cytometer
- ClinicalTrials.gov ID
- NCT05282888
- Acronym / sponsor ID
- ERYSTREAM / PI2021_843_0087
- Conditions
- Red Blood Cells, Schistocytes, Artificial Intelligence
- Keywords
- Red blood cells, schistocytes, flow imaging, artificial intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 16 Mar 2022 (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.
Erythrocyte morphology analysis is a key step in the diagnosis flowchart of anemia. It is performed on a peripheral blood smear after May Grümwald Giemsa staining. In the context of hemolytic anemias for example, it allows the recognition of therapeutic emergencies such as sickle cell disease crisis, malaria-induced hemolysis and thrombotic microangiopathy, the latter being characterized by the presence of schistocytes and justifying an immediate clinical care. However, cytological analysis of erythrocyte morphology requires pre-analytical interventions (smear spreading + staining), the quality of which determines the accuracy of the result. Moreover, it requires a good cytological expertise and may be sometimes subjective. For several years, alternative methods for erythrocyte morphology evaluation have been developed, based on automated hematology machines or automated microscopy. Nevertheless, none of them has yet proven itself in comparison with cytology, especially in the diagnosis of thrombotic microangiopathies. By combining the advantages of flow cytometry and microscopy, flow imaging appears to be a promising technology for the diagnosis of anemias: it does not require any pre-analytical intervention, does not require any spreading and analyzes a large number of events. Moreover, it can be coupled with artificial intelligence via the generation of an apprenticeship by the constitution of a large image data base, which then allows the recognition of the different red blood cells morphologies without human eyes. The objective of this study is to build a data base containing the main red blood cell morphologies relevant in anemia, and to validate it through a comparison in anemic patients of erythrocyte morphological assessment either directly on whole blood by flow imaging or routinely by cytological analysis of peripheral blood smear after by a trained operator.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient for whom a blood test including a cytological evaluation of RBC morphology is performed in the routine laboratory of CHU Amiens
Key inclusion criteria (1 listed)
- Any patient for whom a blood test including a cytological evaluation of RBC morphology is performed in the routine laboratory of CHU Amiens
Key exclusion criteria (1 listed)
- patients who have opposed the use of their personal data for research work
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 |
|---|---|---|
| blood samplein order to develop a diagnostic assay using an innovative technology by imaging flow cytometry to identify red blood cell morphological anomalies in the diagnosis flowchart of anemia. | Other | – |
Primary outcome
Concordance between classical cytological erythrocyte analysis and ImageStream flow imaging erythrocyte analysis
Time frame: 6 months
The investigators will characterize by flow imaging the normal and pathological erythrocyte morphologies by creating a bank of images representative of the main red blood cell abnormalities observed during anemias. The images will be classified manually by the investigators in order to create a morphological data base allowing apprenticeship via artificial intelligence. Once the database will be created, the investigators will validate it prospectively by comparison between classical cytological analysis and flow imaging on samples for which a blood test will be prescribed for anemia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Red Blood Cells and Schistocytes, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between classical cytological erythrocyte analysis and ImageStream flow imaging erythrocyte analysis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.