Condition category
Not Applicable
Date applied
24/11/2020
Date assigned
11/12/2020
Last edited
10/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Optical microscopy remains the gold standard technique for diagnosing several tens of pathologies by manually reviewing samples under a microscope. Microscopic examination and classification of cells that form blood cells is a critical step for the diagnosis of blood diseases. However, it is a laborious, time-consuming technique and its results are subject to the expert examining the sample. Bone marrow aspiration (BMA) biopsies are carried out in order to diagnose many blood diseases, such as leukaemia.
This study aims to prove that the proposed digital solution will reduce time, costs and distances of microscopy diagnosis. To do so, we are generating a correctly annotated database that can be used to train Artificial Intelligence models that will help in blood disease diagnosis.

Who can participate?
Subjects with suspected hematological diseases attending 12 Octubre Hospital for a BMA procedure who are willing to provide a bone marrow sample. Also, professional hematologists who are expert at analyzing the bone marrow samples will participate.

What does the study involve?
Patients will provide a bone marrow sample that will be analysed using the AI system and also by a number of experts. The agreement between the expert analysis will be measured. Also the experts will fill in questionnaires assessing their satisfaction with the AI system.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Hospital Universitario 12 de Octubre (Spain)

When is the study starting and how long is it expected to run for?
September 2020 to December 2021

Who is funding the study?
European Union Horizon 2020

Who is the main contact?
Dr María Linares (scientific), mlinares@ucm.es
Elisa Álamo García-Donas (public), elisa@spotlab.org

Trial website

Contact information

Type

Scientific

Primary contact

Dr María Linares Gómez

ORCID ID

http://orcid.org/0000-0003-3180-6560

Contact details

Paseo de Juan XXIII
36B
Madrid
28040
Spain
+34 686598450
mlinares@ucm.es

Type

Public

Additional contact

Miss Elisa Álamo García-Donas

ORCID ID

Contact details

Paseo de Juan XXIII
36B
Madrid
28040
Spain
+34 675574488
elisa@spotlab.org

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

v2.0

Study information

Scientific title

Evaluation of a digital ecosystem leveraging mobile technology and artificial intelligence for digitalization and remote analysis of bone marrow samples

Acronym

MEDUL-AI

Study hypothesis

The proposed system will convert the current microscopes into digital microscopes connected to a comprehensive cloud platform that will enable images of BMA samples to be archived securely for remote review and clinical management. The possibility of a standardized digitalization of microscopy smears dramatically enhances diagnosis capabilities, as it enables remote diagnosis, second clinical opinion consultations, and helps to achieve automatization of the procedure as it serves as a way of gathering data to develop artificial intelligence tools that will ease the diagnosis process.

Ethics approval

Approved 12/11/2020 Ethics Committee of Clinical Research Hospital Universitario 12 de Octubre (Av. de Córdoba s/n 28041 Madrid, Spain; +34 91 7792613; maria.ugalde@salud.madrid.org), ref: CEIm: 20/430

Study design

Single center observational

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional file (in Spanish)

Condition

Training of convolutional neural network algorithms for identification and counting of cellular lineages and specific cell types of bone marrow

Intervention

This is a one-centre, observational study to evaluate benefits of digitalization of collected BM samples in Hospital Universitario 12 Octubre from patients with suspected hematological disease. Generated data will be used to train convolutional neural network algorithms for identification and counting of cellular lineages and specific cell types of bone marrow.

The samples will belong to patients visiting the hematology outpatient clinic for a BMA procedure at Hospital Universitario 12 Octubre (Madrid).
The execution of the study consists of 2 phases:
Phase 1: Digitalization of routine procedure for BMA analysis of Hospital 12 de Octubre, and generation of BMA tagged image database for AI algorithm development.
Phase 2: Integration and evaluation of AI model as a tool for assisting hematologists in cell counting of BMA samples.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

1. Number of samples analysed by web platform (TeleSpot) and analysis time per sample
2. Professionals' satisfaction measured with the new system measured by a usability report based on the results from a system usability scale (SUS) and AdaptaSpot Usability Questionnaire evaluating the remote analysis process. The SUS and the product questionnaires are completed every three months during the length of the study

Secondary outcome measures

1. Number of digitized bone marrow aspirate images correctly marked and tagged
2. Accuracy of the AI algorithm developed and the % of agreement among experts and AI algorithm. Cell-type classification performance will be tested by assessing the prediction quality of the algorithm in the validation set compared to the ground truth annotated by the specialist during the labelling phase.

Overall trial start date

01/09/2020

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients:
1. Suspected hematological disease
2. Signed informed consent

Bone marrow samples:
1. Good quality BMA sample (with proper staining and lump to provide sufficient quality and quantity)

Professionals/experts:
1. Sanitary professionals of the National Health System (Doctors, Cytologists) working at Hematology Department of the Hospital Universitario 12 Octubre with microscopy experience on hematological diseases

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Assuming the hospital performs 25 BMA procedures a week, and as the data collection period is 10 months long, around 1,000 BMA samples will be eligible to participate in the study.

Participant exclusion criteria

Patients:
1. Individuals unwilling to participate in the study
2. Unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrollment

Bone marrow samples:
1. BMA samples that do not have a good quality stain
2. BMA samples with insufficient lump

Recruitment start date

01/12/2020

Recruitment end date

31/10/2021

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitario 12 de Octubre
Av. de Córdoba s/n
Madrid
28041
Spain

Trial participating centre

SpotLab S.L.
Paseo de Juan XXIII, 36B
Madrid
28040
Spain

Sponsor information

Organisation

SpotLab S.L.

Sponsor details

Paseo de Juan XXIII
36B
Madrid
28040
Spain
+34 916256927
elisa@spotlab.org

Sponsor type

Industry

Website

http://www.spotlab.org

Funders

Funder type

Government

Funder name

Horizon 2020 (grant no. 881062)

Alternative name(s)

European Union Framework Programme for Research and Innovation, EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Results and Publications

Publication and dissemination plan

Any public disclosure including press releases, professional meetings, written publications, oral presentations, marketing purposes or similar shall be subject to the mutual approval of the Parties, and approval shall not be unreasonably withheld or delayed. Any written disclosure will be sent to the Parties within 20 days prior of its publication for review.
The results will be made public within 24 months of reaching the end of the study. The end of the study is the time point at which the last data items are to be reported, or after the outcome data are sufficiently mature for analysis, as defined in the section on Sample Size, Accrual Rate and Study Duration. If a report is to be published in a peer-reviewed journal, that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors. A full report of the outcomes should be made public no later than three (3) years after the end of the study.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/11/2020: Trial’s existence confirmed by Hospital Universitario 12 de Octubre.