NCT04551235

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

August 28, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

3.3 years

First QC Date

August 27, 2020

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

there are not any interventions in this study

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have suspected or confirmed hematological diseases and receive bone marrow or peripheral blood cell morphological examination in National Taiwan University Cancer Center

You may qualify if:

  • 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

You may not qualify if:

  • Patients who are not willing to sign informed consents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Tai-Chen Cell Therapy Center

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 16, 2020

Study Start

August 28, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations