Monitoring genetic changes in low-risk MDS patients using blood samples
Official title: Monitoring Mutational Burden in Low Risk MDS Patients Using Sequential Peripheral Blood Samples
Run by Josep Carreras Leukaemia Research Institute · NCT04251078 · Data updated 2026-11-12
This study is testing if analyzing blood samples for genetic changes can help doctors better understand and manage low-risk myelodysplastic syndromes without needing to do painful bone marrow biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Josep Carreras Leukaemia Research Institute Academic / other |
| Locations | 1 site (Badalona, Barcelona) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | June 1, 2025 |
| Study ends | June 30, 2025 |
| Registry record updated | February 21, 2025 |
| Trial ID | NCT04251078 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with very low, low, or intermediate risk MDS who are not undergoing treatment or are only receiving supportive care.
✕Probably not a fit
Patients with isolated del(5q) MDS or those receiving disease-modifying therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with myelodysplastic syndromes (MDS) categorized as very low, low, or intermediate risk. It aims to utilize next-generation sequencing (NGS) to analyze peripheral blood samples for genetic mutations, providing a less invasive alternative to traditional bone marrow biopsies. By monitoring mutational burden over time, the study seeks to enhance diagnostic and prognostic criteria for MDS management. The research will help establish standards for the application of NGS in routine clinical diagnostics.
Why it matters
Potential benefit: If successful, this approach could lead to improved monitoring and management of MDS, reducing the need for painful procedures.
How similar studies have gone: Other studies have shown promise in using NGS for similar applications, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients categorized as very low, low or intermediate risk according to the Revised International Prognosis Scoring System for MDS (IPSS-R). * Patients that meet the previous criteria and are not receiving any treatment or are receiving supportive care only (erythropoietin is accepted). Exclusion Criteria: * Patients with "MDS with isolated del(5q)" diagnosis, according to 2017 World Health Organization Classification (WHO). * Patients receiving any disease modifying therapies (e.g. hypomethylating agents).
Where it's running
-
Josep Carreras Leukaemia Research Institute
Badalona, Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Francesc Sole, PhD
- Email: fsole@carrerasresearch.org
- Phone: (+34) 93 557 28 06
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.