Status:
COMPLETED
Survey on QUality of Life In myeloDisplasia (SQUID)
Lead Sponsor:
Janssen-Cilag S.p.A.
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome)...
Detailed Description
In low-risk Myelodysplastic Syndrome (MDS), anemia is the major clinical problem and often represents the principal cause of symptoms which negatively influence quality of life (QoL). Moreover anemia ...
Eligibility Criteria
Inclusion
- Primary or secondary MDS
- At least one cytopenia according to International Prognostic Score System (IPSS) criteria (Hb \< 10 g/dL
- Absolute neutrophils count (a type of white cell that fights against infection) \< 1.800/µL
- platelets (irregularly shaped cells found in blood that help prevent bleeding) \< 100.000/µL)
- Willing and able, based on investigator's judgment, to fill in QoL questionnaires
Exclusion
- Refractory anemia with excess blasts (tumor cells located in the marrow \> 20%)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) \>3
- History of cerebrovascular disease with cognitive outcomes
- Psychiatric diseases or senile or vascular dementia
- Positive anamnesis for another clinically active tumor or when treatment has been stopped since less than 5 years
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00967564
Start Date
March 1 2007
End Date
November 1 2009
Last Update
April 28 2014
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