Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells

Acute Leukemia Clinical Trial

Official title:

Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04551235
• Other study ID #: 202007086RIPB
• Status: Recruiting
• Start date: August 28, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: National Taiwan University Hospital
• Contact: Bor-Sheng Ko
• Phone: 886-0-72651297
• Email: kevinkomd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Counting and classification of blood cells in a bone marrow smear and peripheral blood smear are essential to clinical hematology. To this date, this procedure has been carried out in a manual manner in the great majority of clinical settings. There is often inconsistency in the counting result between different operators largely due to its manual nature. There has not been an effective and standard method for blood smear preparation and automatic counting and classification. The recent advent of deep neural network for medical image processing introduced new opportunities for an effective solution of this long-standing problem. Numerous results have been published on the effectiveness of convolutional neural network in clinical image recognition task.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who have suspected or confirmed hematological diseases and receive bone

• marrow or peripheral blood cell morphological examination in National Taiwan University Cancer Center

• Patients who are aged more than 20 y/o

Exclusion Criteria:

•Patients who are not willing to sign informed consents

Related Conditions & MeSH terms

• Acute Leukemia
• Artificial Intelligence
• Hematologic Diseases

Intervention

Other:
• there are not any interventions in this study
there are not any interventions in this study

Locations

Country	Name	City	State
Taiwan	National Taiwan University Tai-Chen Cell Therapy Center	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan University Tai-Chen Cell Therapy Center, Biomdcare Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the accuracy of cell counting and classifying between automatic method and manual method through digital microscopic photos of bone marrow smear and peripheral blood smear using deep convolutional neural networks		3 years