Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379945
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-18
Brief Title:
Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System UMBRELLA-SUMMA
Sponsor:
Instituto de Investigación Biomédica de Salamanca
Organization:
Instituto de Investigación Biomédica de Salamanca
Study Overview
Official Title:
Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System UMBRELLA-SUMMA
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UMBRELLA-SUMMA
Brief Summary:
Myelodysplastic Syndromes MDS are heterogeneous clonal diseases characterized by difficult diagnosis complex prognostic stratification and unsatisfactory treatment Based on that UMBRELLA SUMMA aims to provide better clinical management and personalized medicine to MDS patients in Spain through improving diagnosis 1 prognosis 2 and 3 and treatment 2 and facilitating future investigations 4 of the disease
More concretely we propose 1 The application of new technologies such as Optical Genome Mapping OGM in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients 2 To provide all Spanish Group of MDS GESMD members who require it with the newly prognostic stratification of their patients IPSS-M by making Next Generation Sequencing NGS accessible for all of them 3 Validate and improve a new prognostic system AIPSS-MDS previously developed within the GESMD thanks to artificial intelligence one of the tools with the most projection in the field of medicine currently 4 To build and register ISCIII collections of cells genetic material andor plasma from all prospective MDS patients
On the other hand the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient Based on that the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups normal karyotype trisomy 8 and 5q deletion The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches
More concretely we propose 1 The application of new technologies such as Optical Genome Mapping OGM in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients 2 To provide all Spanish Group of MDS GESMD members who require it with the newly prognostic stratification of their patients IPSS-M by making Next Generation Sequencing NGS accessible for all of them 3 Validate and improve a new prognostic system AIPSS-MDS previously developed within the GESMD thanks to artificial intelligence one of the tools with the most projection in the field of medicine currently 4 To build and register ISCIII collections of cells genetic material andor plasma from all prospective MDS patients
On the other hand the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient Based on that the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups normal karyotype trisomy 8 and 5q deletion The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PI2024 01 1484 | REGISTRY | Ethics Committee for Drug Research of the Salamanca Health Area | None |