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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03755856
Other study ID # GIMEMA-EORTC 1621-QLG-LG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 16, 2019
Est. completion date December 2022

Study information

Verified date March 2020
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Francesca Tartaglia
Phone +39 06 441639837
Email f.tartaglia@gimema.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
Questionnaire
Health-related quality of life

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Croatia,  France,  Italy,  North Macedonia,  Slovakia,  Slovenia,  Turkey, 

Outcome

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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