Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 6:58 PM
Study NCT ID:
NCT04053933
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-07', 'size': 691455, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-07T10:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in QUALMS-score', 'timeFrame': '6 months', 'description': 'Change in quality of life-score after the start of a new MDS related treatment'}, {'measure': 'Change in IPQ-score', 'timeFrame': '6 months', 'description': 'Change of ilness perception score after the start of a new MDS related treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['QUALMS', 'MDS', 'Be-QUALMS', 'Quality of life', 'QoL'], 'conditions': ['Myelodysplastic Syndromes']}, 'referencesModule': {'references': [{'pmid': '37444406', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Study type An observational study conducted in different hematological centers in Belgium.\n\nStudy objectives\n\nPrimary objective:\n\nTo assess the impact of newly started treatments on the QOL of patients suffering from myelodysplastic syndromes.\n\nSecondary objectives:\n\n* To assess the impact of newly started therapy on disease perception in MDS patients\n* To study the relation between disease perception and quality of life\n* To examine which clinical and disease specific factors determine QOL in MDS patients\n* Collect information on the transfusion threshold in Belgian hematological centers and evaluate the impact on quality of life.\n* To evaluate whether changes in QOL are related to hematological respons.\n\nStudy design\n\n* 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.\n* QOL assessment with the QUALMS.\n* Disease perception measurement using the B-IPQ.\n* Measurement at diagnosis/before start of therapy, at 4 weeks, 12 weeks, and at 24 weeks into treatment.\n\nStudy endpoints\n\nPrimary endpoint:\n\nChange in QUALMS score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment.\n\nSecondary endpoint:\n\n* Change in B-IPQ score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment\n* Association between B-IPQ and QUALMS score.\n* Association between clinical and disease specific factors and QUALMS score\n* Association between transfusion threshold and QUALMS score.\n* Association between hematological response and QUALMS score\n\nSummary of eligibility criteria\n\n* 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.\n* Signed informed consent.\n* Patients enrolled in an unblinded interventional therapeutic trial are eligible.\n\nExclusion criteria\n\n* Patients with acute leukemia defined as \\>20% bone marrow blasts.\n* Patients suffering from an overlap syndrome myelodysplastic/myeloproliferative disease.\n* Patients in post allogeneic transplant setting.\n* Patients enrolled in a blinded interventional therapeutic trial.\n* Patients starting with multiple treatments under investigation at the same moment apart from intensive chemotherapy.\n* Newly diagnosed patients who do not start with treatment.\n* Patients who started a previous treatment less then 12 weeks ago apart from packed cell transfusion (up to 4 weeks allowed).\n* 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.\n* Patients refusing to sign informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from myelodysplastic syndromes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed patients with myelodysplastic syndromes defined by WHO 2016 criteria that are about to start treatment.\n* Patients with a known diagnosis of MDS, irrespective of IPSS and irrespective of time of diagnosis that are about to start a new therapy.\n* Signed informed consent\n\nExclusion criteria\n\n* Patients with acute leukemia defined as \\>20% bone marrow blasts.\n* 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.\n* Patients in post allogeneic transplant setting.\n* Patients enrolled in a blinded interventional therapeutic trial.\n* Patients starting with multiple MDS treatments at the same moment apart from intensive chemotherapy.\n* Newly diagnosed patients who do not start with treatment.\n* Patients who started a previous MDS related treatment less then 4 weeks ago.\n* Patients who started a previous MDS related treatment less then 12 weeks ago apart from packed cell transfusions.\n* 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.\n* Patients refusing to sign informed consent'}, 'identificationModule': {'nctId': 'NCT04053933', 'acronym': 'Be-QUALMS', 'briefTitle': 'Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'A Multicenter Observational Belgian Study Assessing the Impact of Newly Started Treatment on the QOL in Patients Suffering From Myelodysplastic Syndromes.', 'orgStudyIdInfo': {'id': 'B300201938708'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with ESA'}, {'label': "Patients treated with 5'azacitidin"}, {'label': 'Patients treated with deferoxamine'}, {'label': 'Patients treated with deferasirox'}, {'label': 'Patients treated with transfusion only'}, {'label': 'Patients treated with lenalidomide'}, {'label': 'Patients treated with intensive chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Bonheiden', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Imelda', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '2930', 'city': 'Brasschaat', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'AZ KLINA', 'geoPoint': {'lat': 51.2912, 'lon': 4.49182}}, {'zip': '2240', 'city': 'Geel', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Sint-Dimpna Ziekenhuis Geel', 'geoPoint': {'lat': 51.16557, 'lon': 4.98917}}, {'zip': '2500', 'city': 'Lier', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Heilig Hart Ziekenhuis', 'geoPoint': {'lat': 51.13128, 'lon': 4.57041}}, {'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'UZA', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '7100', 'city': 'La Louvière', 'state': 'Henegouwen', 'country': 'Belgium', 'facility': 'CH Jolimont', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '7000', 'city': 'Mons', 'state': 'Henegouwen', 'country': 'Belgium', 'facility': 'CHR Mons Hainaut', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '7000', 'city': 'Mons', 'state': 'Henegouwen', 'country': 'Belgium', 'facility': 'CHU Ambroise Paré', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'country': 'Belgium', 'facility': 'CHU - UCL Namur site Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '9000', 'city': 'Ghent', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9100', 'city': 'Sint-Niklaas', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Nikolaas', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '1000', 'city': 'Brussels', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'Institute Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Jette', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '1200', 'city': 'Woluwe-Saint-Lambert', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}, {'zip': '8000', 'city': 'Bruges', 'state': 'West Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Sint Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '8400', 'city': 'Ostend', 'state': 'West Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Damiaan Oostende', 'geoPoint': {'lat': 51.21551, 'lon': 2.927}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Netwerk Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2610', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GasthuisZusters Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'facility': 'CHR Namur', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'city': 'Ottignies-Louvain-la-Neuve', 'country': 'Belgium', 'facility': 'BR Clinic Saint Pierre Ottignies', 'geoPoint': {'lat': 50.66714, 'lon': 4.55023}}], 'overallOfficials': [{'name': 'Zwi Berneman, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zwi Berneman', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}