RecruitingNot Applicable

Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS

Spain30 participantsStarted 2024-09-20

Plain-language summary

Observational study to evaluate changes in quality of life (QoL) in patients diagnosed with low risk MDS who are red blood cell (abc) transfusion dependent. Changes in QoL will be correlated with patient cardiorespiratory function. Cardiac biomarkers and plasma cytokines will also be evaluated.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. They must be able to understand the study procedures, comply with them, and consent in writing prior to any specific study procedure.
. Must be able to understand the study procedures, comply with them, and give written informed consent prior to any study-specific procedure.
. Adult subjects ≥ 18 years of age with a diagnosis of myelodysplastic syndrome.
. Very low, low or intermediate IPSS-R risk category.
. Subject requires are red blood cell transfusion dependent with the following criteria: requires an average of 2 to 6 units of CH on average over an 8-week period.
. ECOG 0-3.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale

Timeframe: We expect to obtain results in one year from the beginning of the study

Trial details

NCT IDNCT06614595

SponsorFundación para la Investigación Biosanitaria del Principado de Asturias

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-20

Contact for this trial

Teresa Bernal del Castillo

985108000 bernaldelcastillo@gmail.com

View on ClinicalTrials.gov More Low Risk Myelodysplastic Syndromes trials