Clinical trial NCT03755856: Long-term Outcomes for Acute Myeloid Leukemia Patients
Official title: A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
First posted: 2018-11-28
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study patients are acute myeloid leukemia long-term survivors

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of differences in SF-36 scores
timeFrame: At enrollment
Secondary outcomes:
measure: Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
timeFrame: At enrollment
measure: QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.
timeFrame: At enrollment
measure: Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
timeFrame: At enrollment
measure: Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
timeFrame: At enrollment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Liège
country: Belgium
facility: CHR Citadelle-CHU
city: Liège
country: Belgium
facility: University of Liège
city: Rijeka
country: Croatia
facility: KBC Rijeka
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Lyon
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Ancona
country: Italy
facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
city: Bari
country: Italy
facility: U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari
city: Barletta
country: Italy
facility: UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
city: Brindisi
country: Italy
facility: Divisione di Ematologia Ospedale A. Perrino
city: Cagliari
country: Italy
facility: ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
city: Catania
country: Italy
facility: Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
city: Cona
country: Italy
facility: Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
city: Foggia
country: Italy
facility: Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
city: Genova
country: Italy
facility: IRCCS_AOU San Martino-IST.Clinica Ematologica
city: Milano
country: Italy
facility: Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
city: Napoli
country: Italy
facility: UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1
city: Novara
country: Italy
facility: S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
city: Orbassano
country: Italy
facility: Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
city: Padova
country: Italy
facility: Università degli Studi di Padova - Ematologia ed Immunologia Clinica
city: Palermo
country: Italy
facility: U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"
city: Parma
country: Italy
facility: U.O. Ematologia e CTMO- AOU di Parma
city: Piacenza
country: Italy
facility: Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
city: Potenza
country: Italy
facility: Ematologia - Ospedale San Carlo
city: Reggio Emilia
country: Italy
facility: Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
city: Roma
country: Italy
facility: Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
city: Roma
country: Italy
facility: Divisione di Ematologia - Ospedale S.Eugenio
city: Roma
country: Italy
facility: Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)
city: Roma
country: Italy
facility: Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
city: Roma
country: Italy
facility: Roma Divisione Ematologia - Università Campus Bio-Medico
city: Roma
country: Italy
facility: Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia
city: San Giovanni Rotondo
country: Italy
facility: U.O. di Ematologia - Casa Sollievo della Sofferenza
city: Sassari
country: Italy
facility: Ematologia - AOU Sassari
city: Torino
country: Italy
facility: Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
city: Skopje
country: North Macedonia
facility: University Clinic of Hematology-Skopje
city: Bratislava
country: Slovakia
facility: University hospital Bratislava
city: Ljubljana
country: Slovenia
facility: UKC Ljubljana
city: Ankara
country: Turkey
facility: Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit
Study officials:
affiliation: GIMEMA Foundation
name: Fabio Efficace
role: STUDY_CHAIR
affiliation: European Organisation for Research and Treatment of Cancer - EORTC
name: Frédéric Baron
role: STUDY_DIRECTOR
References: