NCT06379945 Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System (UMBRELLA-SUMMA)
| NCT ID | NCT06379945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Biomédica de Salamanca |
| Condition | Myelodysplastic Syndromes |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 and/or 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.
Eligibility Criteria
Inclusion Criteria: * Patients over 18 years old * Patients with a confirmed diagnosis of MDS by cytogenetics and/or morphological analysis * Patients with complete clinical data * Patients who sign the informed consent Exclusion Criteria: * Patients under 18 years old * Patients who do not sign the informed consent
Contact & Investigator
María Díez Campelo, PhD MD
STUDY CHAIR
Instituto de Investigación Biomédica de Salamanca
Frequently Asked Questions
Who can join the NCT06379945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelodysplastic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06379945 currently recruiting?
Yes, NCT06379945 is actively recruiting participants. Contact the research team at mdiezcampelo@usal.es for enrollment information.
Where is the NCT06379945 trial being conducted?
This trial is being conducted at Badalona, Spain, Barcelona, Spain, Pamplona, Spain, Salamanca, Spain.
Who is sponsoring the NCT06379945 clinical trial?
NCT06379945 is sponsored by Instituto de Investigación Biomédica de Salamanca. The principal investigator is María Díez Campelo, PhD MD at Instituto de Investigación Biomédica de Salamanca. The trial plans to enroll 300 participants.