Trial Review

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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:
Condition category
Condition code

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

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)

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

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.

PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.
Trial website
https://clinicaltrials.gov/study/NCT00872768
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00872768