An observational study in Low Risk Myelodysplastic Syndromes, sponsored by Fundación para la Investigación Biosanitaria del Principado de Asturias. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Fundación para la Investigación Biosanitaria del Principado de Asturias · Observational
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.
At inclusion and before red blood cell (rbc) transfusion, patients cardiorespiratory function will be evaluated with an ergospirometer
Likewise, before and after rbc transfusion, patients will be asked to complete the QUALMS, a QoL instrument which will be supplied by Dr. Gregory Abel at Dana-Farber in the U.S., who led its development team.
Before and after rbc transfusion, hemoglobin, pretrasfusional hemoglobin, pre and post cardiac biomarkers troponin and NTproBNP will be collect.Pre and post serum and plasma will also be collected for cytokine analysis.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
This study's planned enrollment of 30 is below the median of 150 across 214 observational studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →Fundación para la Investigación Biosanitaria del Principado de Asturias is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Lower-risk Myelodysplastic syndrome patients, red blood cell transfusion dependent
Subjects must meet all of the following inclusion criteria:
Exclusion criteria
Subject diagnosed with any active neoplasm except:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale
To design a score that help to identify which patients benefit from red blood cell Transfusion in terms of QoL improvement
Time frame: We expect to obtain results in one year from the beginning of the study
Changes in QoL before and after transfusion
QoL will be assessed with QUALMS instrument, The QUALMS is being supplied by Dr. Gregory Abel at Dana-Farber in the U.S., who led its development team. He will collaborate and assist in the interpretation of the HRQoL results.
Time frame: QoL will be asses the day of transfusion and seven days after
Troponin and NTproBNP as predictors for QoL improvement
To evaluate the utility of serum pretransfusional troponine and NTPROBNP as cardiac biomarkers to identify those patients whose QoL improves after the rbc transfusion
Time frame: Troponin and NTproBNP will be analyzed the day of transfusion and seven days after
Cardiorespiratory function
To evaluate the utility of oxygen consumption measured by ergospirometry to evalaute cardiorespiratory function and as a predictor of QoL improvement after rbc transfusion
Time frame: Ergospirometry will be performed at the inclusion in the study
Cytokines
To analyze changes in pro and anti-inflammatory cytokines before and after rbc transfusion
Time frame: Cytokines will be analyzed before abc transfusion and seven days after it
Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for Dec 2025, 15 months after the start.
Of 78 non-industry observational studies under Myelodysplastic Syndromes, half reached primary completion within 96 months of starting (the median), counting those still running; a quarter within 51. This study's planned 15 months is below that.
Counting every sponsor, half of 101 studies reached it within 84 months; a quarter within 34.
How these figures are worked out, and which studies are left out of them.
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Fundación para la Investigación Biosanitaria del Principado de Asturias