Long-term Outcomes for Acute Myeloid Leukemia Patients (1621-QLG-LG)

March 2, 2020 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
343

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Leuven, Belgium
        • Not yet recruiting
        • Uz Gasthuisberg
        • Contact:
          • Johan Maertens
      • Liège, Belgium
        • Not yet recruiting
        • CHR Citadelle-CHU
        • Contact:
          • Aurélie Jaspers
      • Liège, Belgium
        • Not yet recruiting
        • University of Liege
        • Contact:
          • Frédéric Baron
  • Croatia
      • Rijeka, Croatia
        • Not yet recruiting
        • KBC Rijeka
        • Contact:
          • Duska Petranovic
        • Principal Investigator:
          • Dusca Petranovic
      • Zagreb, Croatia
        • Not yet recruiting
        • University Hospital Centre Zagreb
        • Contact:
          • Radovan Petranovic
        • Principal Investigator:
          • Radovan Petranovic
  • France
      • Lyon, France
        • Not yet recruiting
        • Les Hôpitaux Universitaires de Strasbourg
  • Italy
      • Ancona, Italy
        • Recruiting
        • Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
      • Bari, Italy
        • Recruiting
        • U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari
        • Principal Investigator:
          • Francesco Albano
      • Barletta, Italy
        • Not yet recruiting
        • UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
      • Brindisi, Italy
        • Recruiting
        • Divisione di Ematologia Ospedale A. Perrino
      • Cagliari, Italy
        • Not yet recruiting
        • ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
        • Principal Investigator:
          • Claudio Romani
      • Catania, Italy
        • Recruiting
        • Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
      • Cona, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
        • Contact:
          • Maria Ciccone
        • Principal Investigator:
          • Maria Ciccone
      • Foggia, Italy
        • Recruiting
        • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
        • Contact:
          • Silvana Franca Capalbo
        • Principal Investigator:
          • Franca Capalbo
      • Genova, Italy
        • Recruiting
        • IRCCS_AOU San Martino-IST.Clinica Ematologica
        • Contact:
          • Roberto Massimo Lemoli
      • Milano, Italy
        • Recruiting
        • Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
        • Contact:
          • nICOLA Fracchiolla
        • Principal Investigator:
          • Nicola Fracchiolla
      • Napoli, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Napoli, Italy
        • Not yet recruiting
        • UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1
        • Contact:
          • Angiolina Rocino
        • Principal Investigator:
          • Angiolina Roccino
      • Novara, Italy
        • Not yet recruiting
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
        • Principal Investigator:
          • Monia Lunghi
      • Orbassano, Italy
        • Not yet recruiting
        • Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
        • Principal Investigator:
          • Daniela Cilloni
      • Padova, Italy
        • Not yet recruiting
        • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
        • Contact:
          • Carmela Gurrieri
        • Principal Investigator:
          • Carmela Gurrieri
      • Palermo, Italy
        • Recruiting
        • U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"
        • Contact:
          • Maria Enza Mitra
      • Parma, Italy
        • Recruiting
        • U.O. Ematologia e CTMO- AOU di Parma
        • Contact:
          • Monica Cugnola
        • Principal Investigator:
          • Monica Cugnola
      • Piacenza, Italy
        • Recruiting
        • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
        • Principal Investigator:
          • Daniele Vallisa
      • Potenza, Italy
        • Recruiting
        • Ematologia - Ospedale San Carlo
        • Contact:
          • Nunzio Filardi
        • Principal Investigator:
          • Nunzio Filardi
      • Reggio Emilia, Italy
        • Recruiting
        • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
        • Contact:
          • Imovilli Annalisa
        • Principal Investigator:
          • Imovilli Annalisa
      • Roma, Italy
        • Recruiting
        • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
      • Roma, Italy
        • Recruiting
        • Divisione di Ematologia - Ospedale S.Eugenio
      • Roma, Italy
        • Recruiting
        • Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)
        • Contact:
          • Luca Maurillo
      • Roma, Italy
        • Recruiting
        • Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma, Italy
        • Recruiting
        • Roma Divisione Ematologia - Università Campus Bio-Medico
        • Contact:
          • Giuseppe Avvisati
        • Principal Investigator:
          • Giuseppe Avvisati
      • Roma, Italy
        • Recruiting
        • Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia
      • San Giovanni Rotondo, Italy
        • Recruiting
        • U.O. di Ematologia - Casa Sollievo della Sofferenza
      • Sassari, Italy
        • Recruiting
        • Ematologia - AOU Sassari
      • Torino, Italy
        • Recruiting
        • Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
  • North Macedonia
      • Skopje, North Macedonia
        • Not yet recruiting
        • University Clinic of Hematology-Skopje
        • Contact:
          • Irina Panovska
        • Principal Investigator:
          • Irina Panovska
  • Slovakia
      • Bratislava, Slovakia
        • Not yet recruiting
        • University Hospital Bratislava
        • Contact:
          • Martin Mistrik
        • Principal Investigator:
          • Martin Mistrik
  • Slovenia
      • Ljubljana, Slovenia
        • Not yet recruiting
        • UKC Ljubljana
        • Contact:
          • Matevz Skerget
        • Principal Investigator:
          • Matevz Skerget
  • Turkey
      • Ankara, Turkey
        • Not yet recruiting
        • Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit
        • Contact:
          • Maltem Yuksel
        • Principal Investigator:
          • Maltem Yuksel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study patients are acute myeloid leukemia long-term survivors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of differences in SF-36 scores
Time Frame: At enrollment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
Time Frame: At enrollment
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
QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.
Time Frame: At enrollment
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
Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
Time Frame: At enrollment
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
Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.
Time Frame: At enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Italiano Malattie EMatologiche dell'Adulto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Frédéric Baron, European Organisation for Research and Treatment of Cancer - EORTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GIMEMA-EORTC 1621-QLG-LG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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