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NCT04212390: FISiM-NGS-MDS
Personalized Medicine Program on Myelodysplastic Syndromes: Characterization of the Patient's Genome for Clinical Decision Making and Systematic Collection of Real World Data to Improve Quality of Health Care
trial in MDS (Myelodysplastic Syndrome) in 1,000 participants. Completed in 18 July 2024.
18 July 2024
Quick facts
| Lead sponsor | Fondazione Italiana Sindromi Mielodisplastiche-ETS |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 3 June 2020 |
| Primary completion | 18 July 2024 |
| Estimated completion | 18 July 2024 |
| Sites | 2 locations across Italy |
Conditions studied
- MDS (Myelodysplastic Syndrome) — all drugs for MDS (Myelodysplastic Syndrome) →
Sponsor
Fondazione Italiana Sindromi Mielodisplastiche-ETS — full company profile →
Who can join
Adults 18 to 100, any sex, with MDS (Myelodysplastic Syndrome). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
BACKGROUND Myelodysplastic syndromes (MDS) typically occur in elderly people and with time, a portion of the patients evolve into acute myeloid leukemia (AML). Therefore a risk-adapted treatment strategy is mandatory. Current prognostic scores present limitations, and in most cases fail to capture reliable prognostic information at individual level. STATE OF THE ART Important steps forward have been made in defining the molecular architecture of MDS and gene mutations have been reported to influence survival and risk of disease progression in MDS. Evaluation of the mutation status may add significant information to currently used prognostic scores and a comprehensive analyses of large, prospective patient populations is warranted to correctly estimate the independent effect of each mutation on clinical outcome and response to treatments. AIMS In this project, the investigators will develop a research platform by integrating genomic mutations, clinical variables and patient outcome derived from real-world data obtained from FISiM (Fondazione Italiana Sindromi Mielodisplastiche) clinical network, including 72 hematological centers. This will allow the investigators to: 1. define the clinical utility of mutational screening in the diagnostic work-up and classification of MDS 2. assess the implementation of diagnostic and therapeutic guidelines (appropriateness) in the real-life 3. evaluate the impact of specific interventions (treatments) on clinical outcomes, long-term complications and costs 4. identify predictors of response to specific treatments, and develop precision medicine programs in hematology based on Real World Evidence RWD 5. measure patient-reported outcomes (PRO) and quality of life (QoL) in a real world MDS setting
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04212390
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for MDS (Myelodysplastic Syndrome)
Currently open trials in the same condition.
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- NCT07511829 — WearAble Technology for Collecting Health Data in People Who Are the Transfused (WATCH Transfused) - A UK Exploratory St · recruiting
- NCT07400341 — Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA · Phase 2 · recruiting
- NCT07347171 — A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies · Phase 1 · recruiting
- NCT05589896 — A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantat · Phase 1, PHASE2 · recruiting
Other Fondazione Italiana Sindromi Mielodisplastiche-ETS trials
Trials by the same sponsor.
- NCT05520749 — Efficacy and Safety of Luspatercept: a Study by Fondazione Italiana Sindromi Mielodisplastiche · completed
- NCT03920657 — Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Ove · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04212390 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Italiana Sindromi Mielodisplastiche-ETS
- Last refreshed: 4 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04212390.
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