Low Risk Myelodysplastic SyndromesMDS-QUALNCT06614595
Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS
An observational study of Low Risk Myelodysplastic Syndromes, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Risk Myelodysplastic Syndromes
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2024to 21 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lower-risk Myelodysplastic syndrome patients, red blood cell transfusion dependent
Who may be able to join
None listed.
Who cannot join
- Subject undergoing any of the following treatments: azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon or interleukin.
- High or very high IPSS-R risk category.
- Subject diagnosed with any active neoplasm except:
- epidermoid or basal cell carcinoma,
- carcinoma in situ of the uterine cervix
- Carcinoma in situ of the breast
Show all 14Show fewer
- Subjects with a score on the New York Heart Association Scale IV.
- Subjects with major surgery within 8 weeks prior to study inclusion. Subjects must have fully recovered from any previous surgery prior to inclusion in the study.
- Subject with known clinically significant anaemia due to iron, vitamin B12 or folate deficiencies or autoimmune or hereditary haemolytic anaemia or uncontrolled hypothyroidism or known clinically significant haemorrhage or sequestration or subject with drug induced anaemia.
- New onset or uncontrolled seizures.
- Subjects with uncontrolled systemic fungal, bacterial or viral infections (defined as ongoing signs or symptoms related to the infection without improvement despite appropriate antibiotics or antimicrobial therapy).
- Pregnant or breastfeeding women.
- The subject has any condition, including the presence of laboratory abnormalities that would place the subject at unacceptable risk if he/she were to participate in the study.
- The subject has any condition or receives concomitant medication that confounds the ability to interpret the study data.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
985108000 ext. 37613, bernaldelcastillo@gmail.com
Teresa Bernal del CastilloBernal del Castillo
About this study
Official title: Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life Changes
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.
Read the detailed description
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.
- Conditions
- Low Risk Myelodysplastic Syndromes
- Keywords
- Myelodysplastic Syndromes, Red blood cell transfusion, Quality of life
- Medical subject headings
- Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: We expect to obtain results in one year from the beginning of the study
Secondary outcomes (1)
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.
Measured: QoL will be asses the day of transfusion and seven days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start20 Sep 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Risk Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Central de Asturias
- Responsible party
- Principal investigator, Teresa Bernal del Castillo, Fundación para la Investigación Biosanitaria del Principado de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614595
- Sponsor's protocol ID
- 2024.244
- Acronym
- MDS-QUAL
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abel GA, Efficace F, Buckstein RJ, Tinsley S, Jurcic JG, Martins Y, Steensma DP, Watts CD, Raza A, Lee SJ, List AF, Klaassen RJ. Prospective international validation of the Quality of Life in Myelodysplasia Scale (QUALMS). Haematologica. 2016 Jun;101(6):781-8. doi: 10.3324/haematol.2015.140335. Epub 2016 Mar 4.
PubMed 26944474Abel GA, Klepin HD, Magnavita ES, Jaung T, Lu W, Shallis RM, Hantel A, Bahl NE, Dellinger-Johnson R, Winer ES, Zeidan AM. Peri-transfusion quality-of-life assessment for patients with myelodysplastic syndromes. Transfusion. 2021 Oct;61(10):2830-2836. doi: 10.1111/trf.16584. Epub 2021 Jul 12.
PubMed 34251040
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life Changes
- ClinicalTrials.gov ID
- NCT06614595
- Acronym / sponsor ID
- MDS-QUAL / 2024.244
- Conditions
- Low Risk Myelodysplastic Syndromes
- Keywords
- Myelodysplastic Syndromes, Red blood cell transfusion, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de AsturiasUniversity, hospital or other
- Collaborators
- Hospital Universitario Central de Asturias
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lower-risk Myelodysplastic syndrome patients, red blood cell transfusion dependent
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Subject undergoing any of the following treatments: azacitidine, decitabine, venetoclax, cytotoxic chemotherapy, radiotherapy, arsenic trioxide, interferon or interleukin.
- High or very high IPSS-R risk category.
- Subject diagnosed with any active neoplasm except:
- Subjects with a score on the New York Heart Association Scale IV.
- Subjects with major surgery within 8 weeks prior to study inclusion. Subjects must have fully recovered from any previous surgery prior to inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale
Time frame: We expect to obtain results in one year from the beginning of the study
To design a score that help to identify which patients benefit from red blood cell Transfusion in terms of QoL improvement
1 secondary outcome
Changes in QoL before and after transfusion
Time frame: QoL will be asses the day of transfusion and seven days after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Background: PubMed 26944474Abel GA, Efficace F, Buckstein RJ, Tinsley S, Jurcic JG, Martins Y, Steensma DP, Watts CD, Raza A, Lee SJ, List AF, Klaassen RJ. Prospective international validation of the Quality of Life in Myelodysplasia Scale (QUALMS). Haematologica. 2016 Jun;101(6):781-8. doi: 10.3324/haematol.2015.140335. Epub 2016 Mar 4.
- Background: PubMed 34251040Abel GA, Klepin HD, Magnavita ES, Jaung T, Lu W, Shallis RM, Hantel A, Bahl NE, Dellinger-Johnson R, Winer ES, Zeidan AM. Peri-transfusion quality-of-life assessment for patients with myelodysplastic syndromes. Transfusion. 2021 Oct;61(10):2830-2836. doi: 10.1111/trf.16584. Epub 2021 Jul 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Risk Myelodysplastic Syndromes, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Bernal del Castillo (985108000 ext. 37613, bernaldelcastillo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Quality of Life (QoL) improvement, assessed by an increase in 5 points or more in the QUALMs scale (time frame: We expect to obtain results in one year from the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614595, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.