ERYthrocyte Morphology Using Flow Imaging on ImageSTREAM Cytometer

Artificial Intelligence Clinical Trial

— ERYSTREAM  

Official title:

ERYthrocyte Morphology Using Flow Imaging on ImageSTREAM Cytometer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282888
• Other study ID #: PI2021_843_0087
• Status: Recruiting
• Start date: March 8, 2022
• Est. completion date: August 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Loïc Garçon, Pr
• Phone: 03.22.08.70.00
• Email: Garcon.Loic[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Artificial Intelligence
• Red Blood Cells
• Schistocytes

Intervention

Other:
• blood 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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Hôpital Necker-Enfants Malades

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months