GenoMed4ALL: Improving SCD Classification and Prognosis by AI (GenoMed4ALL)
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ClinicalTrials.gov Identifier: NCT06019208 |
Recruitment Status :
Active, not recruiting
First Posted : August 31, 2023
Last Update Posted : April 12, 2024
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GenoMed4All 'Genomics and Personalized Medicine for all though Artificial Intelligence in Haematological Diseases' aims to advance on individual SCD patients' disease characterisation and to improve the monitoring of patients' health status, optimise clinical therapy guidance and ultimately improved health outcomes by the identification of biomarkers and the development of individual (risk) models in SCD. Genomed4All supports the pooling of genomic, clinical data and other "-omics" health through a secure and privacy respectful data sharing platform based on the novel Federated Learning scheme, to advance research in personalised medicine in haematological diseases thanks to advanced Artificial Intelligence (AI) models and standardised interoperable sharing of cross-border data, without needing to directly share any sensitive clinical patients' data. The SCD Use case will gather multi-modal clinical and -OMICs data from 1,000 SCD patients in 4 EU-MS: France, Italy, Spain and The Netherlands.
In close collaboration with the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet, GA101157011), GENOMED4ALL involves multiple clinical partners from the network, while leveraging on healthcare information and repositories that will be gathered incorporating interoperability standards as promoted by ERN-EuroBloodNet central registry, the European Rare Blood Disorders Platform.
Condition or disease |
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Sickle Cell Disorders |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Genomics and Personalized Medicine for All Though Artificial Intelligence in Haematological Diseases |
Actual Study Start Date : | January 1, 2021 |
Actual Primary Completion Date : | September 30, 2023 |
Estimated Study Completion Date : | December 31, 2024 |
Group/Cohort |
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GENOMED4ALL - SCD patients
Non transplanted SCD patients aged over 1 year.
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- Improving SCD classification [ Time Frame: through study completion, an average of 2 years ]To improve classification of SCD by integrating clinical and hematological information with genomic features. To address this issue, different methods of statistical learning (Dirichlet processes (DP), Bayesian networks (BN)) and machine learning (deep learning physics informed neural network, constrained regression and deep models) will be compared in order to define specific genotype-phenotype correlations and to develop a new disease classification.
- Improve diagnosis of cerebrovascular complications. [ Time Frame: through study completion, an average of 2 years ]Develop an artificial intelligence algorithm for early diagnosis of silent infarcts by analyzing brain magnetic resonance imaging (Radiomics).
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Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients older than 1 year, diagnosed with SCD, all genotypes.
Exclusion Criteria:
- Patients treated with stem cell transplant or gene therapy.
- Patients younger than 1 year old.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06019208
France | |
APHP Henri Mondor | |
Créteil, France, 94000 | |
APHP Necker | |
Paris, France, 75015 | |
Italy | |
Azienda Ospedale Università Padova | |
Padova, Italy, 35121 | |
Netherlands | |
UMC Utrecht | |
Utrecht, Netherlands, 3584 | |
Spain | |
Hospital Universitari Vall d'Hebron Research Institute | |
Barcelona, Spain, 08035 |
Principal Investigator: | Federico Alvarez | Universidad Politecnica de Madrid | |
Principal Investigator: | Gastone Castellani | University of Bologna | |
Principal Investigator: | Raffaella Colombatti | University of Padova | |
Principal Investigator: | Eduard van Beers | UMC Utrecht | |
Principal Investigator: | Marianne de Montalembert | APHP Necker | |
Principal Investigator: | Pablo Bartolucci | APHP Henri Mondor | |
Principal Investigator: | Tiziana Sanavia | University of Torino | |
Principal Investigator: | Petros Kountouris | Cyprus Institute of Neurology and Genetics | |
Principal Investigator: | Matteo Della Porta | Istituto Clinico Humanitas | |
Principal Investigator: | Maria del Mar Mañú Pereira | Hospital Universitari Vall d'Hebron Research Institute |
Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
ClinicalTrials.gov Identifier: | NCT06019208 |
Other Study ID Numbers: |
928338 |
First Posted: | August 31, 2023 Key Record Dates |
Last Update Posted: | April 12, 2024 |
Last Verified: | June 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Artificial Intelligence Hematological diseases GWAS Personalized medicine Prognosis |
Disease classification Sickle cell disease Radiomics Metabolomics Clinical unmet needs |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |