Spanish database study maps real-world MDS care
NCT ID NCT07465029
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study uses a large Spanish database to understand how many people have transfusion-dependent lower-risk myelodysplastic syndromes (MDS) and what treatments they receive first. Researchers will look at medical records of about 1,300 adults to see patterns in care and health outcomes. The goal is to gather information, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of adult participants diagnosed with transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) identified in Spain using the BIG-PAC® database
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years at the time of lower-risk myelodysplastic syndromes (LR-MDS) diagnosis. * Documented diagnosis of LR-MDS identified through International Classification of Diseases (ICD) 9 codes recorded in medical history. In addition, recorded diagnosis of MDS with an explicitly documented International Prognostic Scoring System (IPSS) category of low or intermediate-1 and/or revised IPSS category of very low or low at or around the index date. * Evidence of transfusion dependence, defined as receiving ≥2 red blood cell (RBC) units within an 8-week interval, occurring within the selection window (January 1, 2021, to May 31, 2025, or the latest date ensuring detectable follow-up). * Active participants in BIG-PAC®, defined as ≥1 claim of any kind within 12 months prior to or on the index date (baseline period). * A minimum of 6 months of follow-up data available after the index date, unless the patient dies earlier Exclusion Criteria: * Diagnosis of high-risk MDS (HR-MDS) or another hematologic malignancy (e.g., acute myeloid leukemia) before the index date. * Documented transformation to acute myeloid leukemia (AML) or HR-MDS occurring before initiation of first-line treatment. * Participation in interventional clinical trials during the period of first-line treatment. * Presence of anemia secondary to non-MDS-related causes, such as nutritional deficiencies, advanced chronic kidney disease, or active bleeding, when such conditions preclude accurate attribution of transfusion dependence to MDS. * Lack of sufficient clinical history, defined as \<12 months of observable data before the index date. * Have missing key variables, e.g., age or sex. * Incomplete or inconsistent clinical information that prevents reliable evaluation of key study variables, including transfusion dependence status, treatment patterns, or outcomes.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Local Institution - 0001
Madrid, 28001, Spain