Long-term Outcomes for Acute Myeloid Leukemia Patients

NCT ID: NCT03755856

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-16

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Questionnaire

Health-related quality of life

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabio Efficace

Role: STUDY_CHAIR

GIMEMA Foundation

Frédéric Baron

Role: STUDY_DIRECTOR

European Organisation for Research and Treatment of Cancer - EORTC

Locations

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UZ Gasthuisberg

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

CHR Citadelle-CHU

Liège, , Belgium

Site Status NOT_YET_RECRUITING

University of Liège

Liège, , Belgium

Site Status NOT_YET_RECRUITING

KBC Rijeka

Rijeka, , Croatia

Site Status NOT_YET_RECRUITING

University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status NOT_YET_RECRUITING

Les Hôpitaux Universitaires de Strasbourg

Lyon, , France

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI

Ancona, , Italy

Site Status RECRUITING

U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari

Bari, , Italy

Site Status RECRUITING

UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"

Barletta, , Italy

Site Status NOT_YET_RECRUITING

Divisione di Ematologia Ospedale A. Perrino

Brindisi, , Italy

Site Status RECRUITING

ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

Cagliari, , Italy

Site Status NOT_YET_RECRUITING

Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto

Catania, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

Cona, , Italy

Site Status RECRUITING

Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

Foggia, , Italy

Site Status RECRUITING

IRCCS_AOU San Martino-IST.Clinica Ematologica

Genova, , Italy

Site Status RECRUITING

Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano

Milan, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, , Italy

Site Status RECRUITING

UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1

Napoli, , Italy

Site Status NOT_YET_RECRUITING

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, , Italy

Site Status NOT_YET_RECRUITING

Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2

Orbassano, , Italy

Site Status NOT_YET_RECRUITING

Università degli Studi di Padova - Ematologia ed Immunologia Clinica

Padua, , Italy

Site Status NOT_YET_RECRUITING

U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"

Palermo, , Italy

Site Status RECRUITING

U.O. Ematologia e CTMO- AOU di Parma

Parma, , Italy

Site Status RECRUITING

Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto

Piacenza, , Italy

Site Status RECRUITING

Ematologia - Ospedale San Carlo

Potenza, , Italy

Site Status RECRUITING

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, , Italy

Site Status RECRUITING

Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

Roma, , Italy

Site Status RECRUITING

Divisione di Ematologia - Ospedale S.Eugenio

Roma, , Italy

Site Status RECRUITING

Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)

Roma, , Italy

Site Status RECRUITING

Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, , Italy

Site Status RECRUITING

Roma Divisione Ematologia - Università Campus Bio-Medico

Roma, , Italy

Site Status RECRUITING

Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia

Roma, , Italy

Site Status RECRUITING

U.O. di Ematologia - Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status RECRUITING

Ematologia - AOU Sassari

Sassari, , Italy

Site Status RECRUITING

Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

Torino, , Italy

Site Status RECRUITING

University Clinic of Hematology-Skopje

Skopje, , North Macedonia

Site Status NOT_YET_RECRUITING

University hospital Bratislava

Bratislava, , Slovakia

Site Status NOT_YET_RECRUITING

UKC Ljubljana

Ljubljana, , Slovenia

Site Status NOT_YET_RECRUITING

Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Countries

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Belgium Croatia France Italy North Macedonia Slovakia Slovenia Turkey (Türkiye)

Central Contacts

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Francesca Tartaglia

Role: CONTACT

+39 06 441639837

Facility Contacts

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Johan Maertens

Role: primary

Aurélie Jaspers

Role: primary

Frédéric Baron

Role: primary

Duska Petranovic

Role: primary

Radovan Petranovic

Role: primary

Xavier Thomas

Role: primary

Attilio Olivieri

Role: primary

Francesco Albano

Role: primary

Giuseppe Tarantini

Role: primary

Domenico Pastore

Role: primary

Claudio Romani

Role: primary

Francesco Di Raimondo

Role: primary

Maria Ciccone

Role: primary

Silvana Franca Capalbo

Role: primary

Roberto Massimo Lemoli

Role: primary

Nicola Fracchiolla

Role: primary

Fabrizio Pane

Role: primary

Angiolina Rocino

Role: primary

Monia Lunghi

Role: primary

Daniela Cilloni

Role: primary

Carmela Gurrieri

Role: primary

Maria Enza Mitra

Role: primary

Monica Cugnola

Role: primary

Daniele Vallisa

Role: primary

Nunzio Filardi

Role: primary

Imovilli Annalisa

Role: primary

Agostino Tafuri

Role: primary

Paolo De Fabritiis

Role: primary

Luca Maurillo

Role: primary

Simona Sica

Role: primary

Giuseppe Avvisati

Role: primary

Maurizio Martelli

Role: primary

Nicola Cascavilla

Role: primary

Claudio Fozza

Role: primary

Ernesta Audisio

Role: primary

Irina Panovska

Role: primary

Martin Mistrik

Role: primary

Matevz Skerget

Role: primary

Maltem Yuksel

Role: primary

Other Identifiers

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GIMEMA-EORTC 1621-QLG-LG

Identifier Type: -

Identifier Source: org_study_id

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