Acute Myeloid Leukemia Clinical Trial
— 1621-QLG-LGOfficial title:
A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform
This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.
Status | Recruiting |
Enrollment | 343 |
Est. completion date | December 2022 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of all subtypes of de novo AML, according to WHO criteria (at least 20% blasts in the bone marrow), except acute promyelocytic leukemia (APL). - Age at AML diagnosis = 18 years, - Date of AML diagnosis at least 5 years before study enrollment, - AML-free status at study enrollment, - Written informed consent provided. Exclusion Criteria: - Major cognitive deficit or psychiatric problems hampering a self-reported evaluation, - Not speaking and reading the language of the participating country, - More than 75 years at the time of study enrollment, - Receiving any active treatment for AML at the time of study enrollment. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Gasthuisberg | Leuven | |
Belgium | CHR Citadelle-CHU | Liège | |
Belgium | University of Liège | Liège | |
Croatia | KBC Rijeka | Rijeka | |
Croatia | University Hospital Centre Zagreb | Zagreb | |
France | Les Hôpitaux Universitaires de Strasbourg | Lyon | |
Italy | Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI | Ancona | |
Italy | U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari | Bari | |
Italy | UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli" | Barletta | |
Italy | Divisione di Ematologia Ospedale A. Perrino | Brindisi | |
Italy | ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO | Cagliari | |
Italy | Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto | Catania | |
Italy | Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi | Cona | |
Italy | Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria | Foggia | |
Italy | IRCCS_AOU San Martino-IST.Clinica Ematologica | Genova | |
Italy | Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano | Milano | |
Italy | Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia | Napoli | |
Italy | UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1 | Napoli | |
Italy | S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | Novara | |
Italy | Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 | Orbassano | |
Italy | Università degli Studi di Padova - Ematologia ed Immunologia Clinica | Padova | |
Italy | U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone" | Palermo | |
Italy | U.O. Ematologia e CTMO- AOU di Parma | Parma | |
Italy | Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto | Piacenza | |
Italy | Ematologia - Ospedale San Carlo | Potenza | |
Italy | Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova | Reggio Emilia | |
Italy | Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia | Roma | |
Italy | Divisione di Ematologia - Ospedale S.Eugenio | Roma | |
Italy | Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV) | Roma | |
Italy | Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli | Roma | |
Italy | Roma Divisione Ematologia - Università Campus Bio-Medico | Roma | |
Italy | Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia | Roma | |
Italy | U.O. di Ematologia - Casa Sollievo della Sofferenza | San Giovanni Rotondo | |
Italy | Ematologia - AOU Sassari | Sassari | |
Italy | Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista | Torino | |
North Macedonia | University Clinic of Hematology-Skopje | Skopje | |
Slovakia | University hospital Bratislava | Bratislava | |
Slovenia | UKC Ljubljana | Ljubljana | |
Turkey | Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano Malattie EMatologiche dell'Adulto | European Organisation for Research and Treatment of Cancer - EORTC |
Belgium, Croatia, France, Italy, North Macedonia, Slovakia, Slovenia, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of differences in SF-36 scores | The Role Physical scores of AML survivors will be compared to that in the general population as assessed by SF-36 questionnaire. Comparisons will be performed on age-sex matched pairs of AML patients and healthy subjects from the general population. | At enrollment | |
Secondary | Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs. | Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores | At enrollment | |
Secondary | QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire. | Comparisons will be adjusted by age and sex, using the European reference values for the EORTC QLQ-C30. A subgroup analysis on elderly patients (i.e. 60+ patients) will be also performed. | At enrollment | |
Secondary | Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs. | Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores. | At enrollment | |
Secondary | Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs. | Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores. | At enrollment |
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