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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00872768




Registration number
NCT00872768
Ethics application status
Date submitted
16/12/2008
Date registered
17/12/2008
Date last updated
22/12/2020

Titles & IDs
Public title
Quality of Life and Symptoms in Patients With Newly Diagnosed Myelodysplastic Syndromes
Scientific title
Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study
Secondary ID [1] 0 0
GIMEMA-QOL-MDS-0108
Secondary ID [2] 0 0
QOL-MDS0108
Universal Trial Number (UTN)
Trial acronym
PROMYS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult 0 0
Myelodysplastic Syndromes 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients.
Timepoint [1] 0 0
After 5 years from study entry.
Secondary outcome [1] 0 0
To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes.
Timepoint [1] 0 0
After 5 years from study entry.
Secondary outcome [2] 0 0
To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy.
Timepoint [2] 0 0
After 5 years from study entry.
Secondary outcome [3] 0 0
To compare the QoL of lower risk patients who maintain stable disease versus those who have progressed to AML or higher-risk score categories.
Timepoint [3] 0 0
After 5 years from study entry.
Secondary outcome [4] 0 0
To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.
Timepoint [4] 0 0
After 5 years from study entry.
Secondary outcome [5] 0 0
To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials.
Timepoint [5] 0 0
After 5 years from study entry.
Secondary outcome [6] 0 0
To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes.
Timepoint [6] 0 0
After 5 years from study entry.
Secondary outcome [7] 0 0
To devise a prognostic patient-based index.
Timepoint [7] 0 0
After 5 years from study entry.
Secondary outcome [8] 0 0
To evaluate accuracy of clinical prediction of survival.
Timepoint [8] 0 0
After 5 years from study entry.
Secondary outcome [9] 0 0
To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics.
Timepoint [9] 0 0
After 5 years from study entry.

Eligibility
Key inclusion criteria
Inclusion criteria

* Patients with newly diagnosed myelodysplastic syndrome (MDS) according to WHO classification with any known IPSS risk score category. The initial diagnosis of MDS is acceptable within 3 months before date of registration.
* Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5D; FACIT-Fatigue and Control Preference Scale).
* Adult patients (= 18 years old).
* Written informed consent provided.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

* Patients who have received prior treatment other than platelets or RBC transfusions, iron chelation, antibiotic/virostatic drugs, vitamins;
* Patients with therapy related MDS.
* Having any kind of psychiatric disorder or major cognitive dysfunction.
* Not able to read and understand local language.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2021
Actual
Sample size
Target
Accrual to date
Final
927
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Austria
State/province [3] 0 0
Innsbruck
Country [4] 0 0
Belgium
State/province [4] 0 0
Antwerpen
Country [5] 0 0
Belgium
State/province [5] 0 0
Brugge
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Liege
Country [8] 0 0
Brazil
State/province [8] 0 0
Curitiba
Country [9] 0 0
China
State/province [9] 0 0
China
Country [10] 0 0
China
State/province [10] 0 0
Kunming
Country [11] 0 0
Croatia
State/province [11] 0 0
Rijeka
Country [12] 0 0
Czechia
State/province [12] 0 0
Prague
Country [13] 0 0
France
State/province [13] 0 0
Saint-Cloud
Country [14] 0 0
France
State/province [14] 0 0
Toulouse
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Italy
State/province [17] 0 0
Foggia
Country [18] 0 0
Italy
State/province [18] 0 0
Torino
Country [19] 0 0
Italy
State/province [19] 0 0
Asti
Country [20] 0 0
Italy
State/province [20] 0 0
Bari
Country [21] 0 0
Italy
State/province [21] 0 0
Cagliari
Country [22] 0 0
Italy
State/province [22] 0 0
Catania
Country [23] 0 0
Italy
State/province [23] 0 0
Catanzaro
Country [24] 0 0
Italy
State/province [24] 0 0
Cona
Country [25] 0 0
Italy
State/province [25] 0 0
Firenze
Country [26] 0 0
Italy
State/province [26] 0 0
Genova
Country [27] 0 0
Italy
State/province [27] 0 0
Latina
Country [28] 0 0
Italy
State/province [28] 0 0
Lecce
Country [29] 0 0
Italy
State/province [29] 0 0
Meldola
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Modena
Country [32] 0 0
Italy
State/province [32] 0 0
Monza
Country [33] 0 0
Italy
State/province [33] 0 0
Novara
Country [34] 0 0
Italy
State/province [34] 0 0
Orbassano
Country [35] 0 0
Italy
State/province [35] 0 0
Parma
Country [36] 0 0
Italy
State/province [36] 0 0
Pavia
Country [37] 0 0
Italy
State/province [37] 0 0
Piacenza
Country [38] 0 0
Italy
State/province [38] 0 0
Reggio Emilia
Country [39] 0 0
Italy
State/province [39] 0 0
Roma
Country [40] 0 0
Italy
State/province [40] 0 0
Rome
Country [41] 0 0
Italy
State/province [41] 0 0
Rovigo
Country [42] 0 0
Italy
State/province [42] 0 0
Sassari
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Bradford
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Leeds
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Gruppo Italiano Malattie EMatologiche dell'Adulto
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fabio Efficace, PhD
Address 0 0
Gruppo Italiano Malattie EMatologiche dell'Adulto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00872768