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CompletedNCT05282888ERYSTREAMUpdated Jun 15, 2026

ERYthrocyte Morphology Using Flow Imaging on ImageSTREAM Cytometer

An observational study in Red Blood Cells, Schistocytes and Artificial Intelligence, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
14
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Red Blood Cells
  • Schistocytes
  • Artificial Intelligence

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Keywords

  • Red blood cells
  • schistocytes
  • flow imaging
  • artificial intelligence
03

In context

Sickle Cell Trait

43 studies on the registry are indexed under Sickle Cell Trait; 11 are open to participants now.

This study's enrollment of 14 is below the median of 109 across 20 observational studies indexed under Sickle Cell Trait.

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Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any patient for whom a blood test including a cytological evaluation of RBC morphology is performed in the routine laboratory of CHU Amiens

Exclusion criteria

Exclusion Criteria:

  • patients who have opposed the use of their personal data for research work
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Otherblood sample

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • CHU Amiens Picardie
    Amiens, Picardie 80054, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05282888
Collaborators
Hôpital Necker-Enfants Malades
Responsible party
Sponsor
First posted
Mar 16, 2022
Start date
Apr 22, 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2022
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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