Can we use artificial intelligence tools for automatic analysis of bone marrow samples?
| ISRCTN | ISRCTN10382623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10382623 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | v2.0 |
| Sponsor | SpotLab S.L. |
| Funder | Horizon 2020 (grant no. 881062) |
- Submission date
- 24/11/2020
- Registration date
- 11/12/2020
- Last edited
- 13/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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?
November 2020 to May 2022
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
Contact information
Scientific
Paseo de Juan XXIII, 36B
Madrid
28040
Spain
 ORCID ID |
0000-0003-3180-6560 |
|---|---|
| Phone | +34 686598450 |
| mlinares@ucm.es |
Public
Paseo de Juan XXIII, 36B
Madrid
28040
Spain
| Phone | +34 675574488 |
|---|---|
| elisa@spotlab.org |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single center observational |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Evaluation of a digital ecosystem leveraging mobile technology and artificial intelligence for digitalization and remote analysis of bone marrow samples |
| Study acronym | MEDUL-AI |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Number of samples analysed by web platform (TeleSpot) and analysis time per sample |
| Key secondary outcome measure(s) |
1. Number of digitized bone marrow aspirate images correctly marked and tagged |
| Completion date | 30/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/05/2021 |
| Date of final enrolment | 31/03/2022 |
Locations
Countries of recruitment
- Spain
Study participating centres
Madrid
28041
Spain
Madrid
28040
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 13/04/2022 | 13/04/2022 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN10382623_BasicResults_13Apr2022.pdf
- Basic results
Editorial Notes
13/04/2022: A basic results summary has been uploaded.
07/10/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/12/2020 to 17/05/2021.
2. The recruitment end date was changed from 31/10/2021 to 31/03/2022.
3. The overall start date was changed from 01/09/2020 to 12/11/2020.
4. The overall end date was changed from 31/12/2021 to 30/05/2022.
5. The intention to publish date was changed from 01/12/2022 to 01/05/2023.
6. The target number of participants was changed from 1000 to 150
7. The plain English summary was updated to reflect these changes.
25/11/2020: Trial’s existence confirmed by Hospital Universitario 12 de Octubre.
