Myelodysplastic SyndromesBe-QUALMSNCT04053933
Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL
An observational study of Myelodysplastic Syndromes, run by University Hospital, Antwerp at 21 sites in Belgium.
Trial summary
Study type An observational study conducted in different hematological centers in Belgium. Study objectives Primary objective: To assess the impact of newly started treatments on the QOL of patients suffering from myelodysplastic syndromes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- How many people
- 70 participants
- Where
- 21 sitesBelgium
- Study dates
- 1 Aug 2019to 31 Jul 2021
- How long will I take part?
- 6 Months
- 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: Patients suffering from myelodysplastic syndromes
Who may be able to join
- Newly diagnosed patients with myelodysplastic syndromes defined by WHO 2016 criteria that are about to start treatment.
- Patients with a known diagnosis of MDS, irrespective of IPSS and irrespective of time of diagnosis that are about to start a new therapy.
- Signed informed consent
Who cannot join
- Patients with acute leukemia defined as >20% bone marrow blasts.
- Patients suffering from a myelodysplastic/myeloproliferative overlap syndrome. In this case the disease has both dysplastic and proliferative features but cannot be properly categorized to either group. This category includes chronic myelomonocytic leukemia (CMML), juvenile myelomonocytic leukemia (JMML), atypial chronic myeloid leukemia (aCML) and myelodysplastic/myeloproliferative disease unclassifiable.
- Patients in post allogeneic transplant setting.
- Patients enrolled in a blinded interventional therapeutic trial.
- Patients starting with multiple MDS treatments at the same moment apart from intensive chemotherapy.
- Newly diagnosed patients who do not start with treatment.
Show all 10Show fewer
- Patients who started a previous MDS related treatment less then 4 weeks ago.
- Patients who started a previous MDS related treatment less then 12 weeks ago apart from packed cell transfusions.
- Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion.
- Patients refusing to sign informed consent
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Belgium21 sites
Ziekenhuis Netwerk Antwerpen
Antwerp, 2020
GasthuisZusters Antwerpen
Antwerp, 2610
Imelda
Bonheiden, Antwerpen, 2820
AZ KLINA
Brasschaat, Antwerpen, 2930
AZ Sint Jan Brugge
Bruges, West Vlaanderen, 8000
Institute Jules Bordet
Brussels, Vlaams Brabant, 1000
UZA
Edegem, Antwerp, 2650
Sint-Dimpna Ziekenhuis Geel
Geel, Antwerpen, 2240
UZ Gent
Ghent, Oost Vlaanderen, 9000
UZ Brussel
Jette, Vlaams Brabant, 1090
CH Jolimont
La Louvière, Henegouwen, 7100
UZ Leuven Gasthuisberg
Leuven, Vlaams Brabant, 3000
Heilig Hart Ziekenhuis
Lier, Antwerpen, 2500
CHR Mons Hainaut
Mons, Henegouwen, 7000
CHU Ambroise Paré
Mons, Henegouwen, 7000
CHR Namur
Namur, 5000
AZ Damiaan Oostende
Ostend, West Vlaanderen, 8400
BR Clinic Saint Pierre Ottignies
Ottignies-Louvain-la-Neuve
AZ Nikolaas
Sint-Niklaas, Oost Vlaanderen, 9100
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Vlaams Brabant, 1200
CHU - UCL Namur site Godinne
Yvoir, Namur, 5530
About this study
Official title: A Multicenter Observational Belgian Study Assessing the Impact of Newly Started Treatment on the QOL in Patients Suffering From Myelodysplastic Syndromes.
Study type An observational study conducted in different hematological centers in Belgium.
Study objectives
Read more
Primary objective:
To assess the impact of newly started treatments on the QOL of patients suffering from myelodysplastic syndromes.
Secondary objectives:
- To assess the impact of newly started therapy on disease perception in MDS patients
- To study the relation between disease perception and quality of life
- To examine which clinical and disease specific factors determine QOL in MDS patients
- Collect information on the transfusion threshold in Belgian hematological centers and evaluate the impact on quality of life.
- To evaluate whether changes in QOL are related to hematological respons.
Study design
- Newly diagnosed MDS patients who are about to start a treatment or previously diagnosed MDS patients who are starting with a new line of therapy.
- QOL assessment with the QUALMS.
- Disease perception measurement using the B-IPQ.
- Measurement at diagnosis/before start of therapy, at 4 weeks, 12 weeks, and at 24 weeks into treatment.
Study endpoints
Primary endpoint:
Change in QUALMS score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment.
Secondary endpoint:
- Change in B-IPQ score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment
- Association between B-IPQ and QUALMS score.
- Association between clinical and disease specific factors and QUALMS score
- Association between transfusion threshold and QUALMS score.
- Association between hematological response and QUALMS score
Summary of eligibility criteria
- Adult patients with a new diagnosis of MDS (according to WHO 2016 definitions (3) or known patients with MDS who are about to start a new treatment.
- Signed informed consent.
- Patients enrolled in an unblinded interventional therapeutic trial are eligible.
Exclusion criteria
- Patients with acute leukemia defined as >20% bone marrow blasts.
- Patients suffering from an overlap syndrome myelodysplastic/myeloproliferative disease.
- Patients in post allogeneic transplant setting.
- Patients enrolled in a blinded interventional therapeutic trial.
- Patients starting with multiple treatments under investigation at the same moment apart from intensive chemotherapy.
- Newly diagnosed patients who do not start with treatment.
- Patients who started a previous treatment less then 12 weeks ago apart from packed cell transfusion (up to 4 weeks allowed).
- Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion.
- Patients refusing to sign informed consent.
- Conditions
- Myelodysplastic Syndromes
- Keywords
- QUALMS, MDS, Be-QUALMS, Quality of life, QoL
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with ESA | Not described | |
| Patients treated with 5'azacitidin | Not described | |
| Patients treated with deferoxamine | Not described | |
| Patients treated with deferasirox | Not described | |
| Patients treated with transfusion only | Not described | |
| Patients treated with lenalidomide | Not described | |
| Patients treated with intensive chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QUALMS-score
Change in quality of life-score after the start of a new MDS related treatment
Measured: 6 months
Change in IPQ-score
Change of ilness perception score after the start of a new MDS related treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Aug 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- 70 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zwi Berneman, University Hospital, Antwerp
- Investigators
- Zwi Berneman, MD,PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053933
- Sponsor's protocol ID
- B300201938708
- Acronym
- Be-QUALMS
- Status last verified
- Mar 2025
- First submitted
- 9 Aug 2019
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heyrman B, Meers S, De Becker A, Wouters K, Van Hoof A, Van De Velde A, Graux C, Mazure D, Selleslag D, Maes H, Lemmens J, Beckers M, Breems D, Sid S, Berneman Z, Anguille S. Disease Perception Is Correlated with Health-Related Quality of Life in Patients Suffering from Myelodysplastic Syndromes: Results of the Belgian Be-QUALMS Study. Cancers (Basel). 2023 Jun 22;15(13):3296. doi: 10.3390/cancers15133296.
PubMed 37444406
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Belgian Study Assessing the Impact of Newly Started Treatment on the QOL in Patients Suffering From Myelodysplastic Syndromes.
- ClinicalTrials.gov ID
- NCT04053933
- Acronym / sponsor ID
- Be-QUALMS / B300201938708
- Conditions
- Myelodysplastic Syndromes
- Keywords
- QUALMS, MDS, Be-QUALMS, Quality of life, QoL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 13 Aug 2019 (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.
Study type An observational study conducted in different hematological centers in Belgium.
Study objectives
Primary objective:
To assess the impact of newly started treatments on the QOL of patients suffering from myelodysplastic syndromes.
Secondary objectives:
- To assess the impact of newly started therapy on disease perception in MDS patients
- To study the relation between disease perception and quality of life
- To examine which clinical and disease specific factors determine QOL in MDS patients
- Collect information on the transfusion threshold in Belgian hematological centers and evaluate the impact on quality of life.
- To evaluate whether changes in QOL are related to hematological respons.
Study design
- Newly diagnosed MDS patients who are about to start a treatment or previously diagnosed MDS patients who are starting with a new line of therapy.
- QOL assessment with the QUALMS.
- Disease perception measurement using the B-IPQ.
- Measurement at diagnosis/before start of therapy, at 4 weeks, 12 weeks, and at 24 weeks into treatment.
Study endpoints
Primary endpoint:
Change in QUALMS score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment.
Secondary endpoint:
- Change in B-IPQ score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment
- Association between B-IPQ and QUALMS score.
- Association between clinical and disease specific factors and QUALMS score
- Association between transfusion threshold and QUALMS score.
- Association between hematological response and QUALMS score
Summary of eligibility criteria
- Adult patients with a new diagnosis of MDS (according to WHO 2016 definitions (3) or known patients with MDS who are about to start a new treatment.
- Signed informed consent.
- Patients enrolled in an unblinded interventional therapeutic trial are eligible.
Exclusion criteria
- Patients with acute leukemia defined as >20% bone marrow blasts.
- Patients suffering from an overlap syndrome myelodysplastic/myeloproliferative disease.
- Patients in post allogeneic transplant setting.
- Patients enrolled in a blinded interventional therapeutic trial.
- Patients starting with multiple treatments under investigation at the same moment apart from intensive chemotherapy.
- Newly diagnosed patients who do not start with treatment.
- Patients who started a previous treatment less then 12 weeks ago apart from packed cell transfusion (up to 4 weeks allowed).
- Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion.
- Patients refusing to sign informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Patients treated with ESA | – | – |
| Patients treated with 5'azacitidin | – | – |
| Patients treated with deferoxamine | – | – |
| Patients treated with deferasirox | – | – |
| Patients treated with transfusion only | – | – |
| Patients treated with lenalidomide | – | – |
| Patients treated with intensive chemotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from myelodysplastic syndromes
Key inclusion criteria (3 listed)
- Newly diagnosed patients with myelodysplastic syndromes defined by WHO 2016 criteria that are about to start treatment.
- Patients with a known diagnosis of MDS, irrespective of IPSS and irrespective of time of diagnosis that are about to start a new therapy.
- Signed informed consent
Key exclusion criteria (10 listed)
- Patients with acute leukemia defined as >20% bone marrow blasts.
- Patients suffering from a myelodysplastic/myeloproliferative overlap syndrome. In this case the disease has both dysplastic and proliferative features but cannot be properly categorized to either group. This category includes chronic myelomonocytic leukemia (CMML), juvenile myelomonocytic leukemia (JMML), atypial chronic myeloid leukemia (aCML) and myelodysplastic/myeloproliferative disease unclassifiable.
- Patients in post allogeneic transplant setting.
- Patients enrolled in a blinded interventional therapeutic trial.
- Patients starting with multiple MDS treatments at the same moment apart from intensive chemotherapy.
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
Change in QUALMS-score
Time frame: 6 months
Change in quality of life-score after the start of a new MDS related treatment
Change in IPQ-score
Time frame: 6 months
Change of ilness perception score after the start of a new MDS related treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 37444406Heyrman B, Meers S, De Becker A, Wouters K, Van Hoof A, Van De Velde A, Graux C, Mazure D, Selleslag D, Maes H, Lemmens J, Beckers M, Breems D, Sid S, Berneman Z, Anguille S. Disease Perception Is Correlated with Health-Related Quality of Life in Patients Suffering from Myelodysplastic Syndromes: Results of the Belgian Be-QUALMS Study. Cancers (Basel). 2023 Jun 22;15(13):3296. doi: 10.3390/cancers15133296.
- 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.
Zwi Berneman, MD,PhD principal investigator
University Hospital, Antwerp
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by University Hospital, Antwerp at 21 sites in Belgium.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QUALMS-score (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04053933, which also lists 1 linked publication.
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 30 Mar 2025.