Myelodysplastic Syndromes
Conditions
Keywords
Hematology, Elderly, High Risk Myelodysplastic Syndrome
Brief summary
No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. The impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value. The main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use. To best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. In testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients'care and prognosis according to the use or not by the doctors of the new scores. Research outcomes are various medical, economic and ethic. Medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. Ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. This project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.
Interventions
OTHERresearch of disease-related factors
included in IPSS and IPSS-R, lactate dehydrogenase, ferritin level, transfusion- dependence, molecular markers as genes mutations
OTHERresearch of comorbidities
HCT-Comorbidity Index, MDS-Comorbidity Index, Adult Comorbidity Evaluation-27, Cumulative Illness Rating Scale-G
OTHERphysical performance
Activities of Daily Living and physical performance
Sponsors
National Cancer Institute, France
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of HR-MDS inferior to 6 weeks, * No treatment received before inclusion, * IPSS superior to 1 (intermediate 2 and high risk IPSS categories), * Social system affiliation, * Informed consent signed.
Exclusion criteria
* Patient eligibility to stem cell transplantation, * IPSS inferior or egal 1 (low or intermediate 1 IPSS), * Concomitant investigational trial participation, which could interfere, * Patients under legal protection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPPS score | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| percentage of patients who had adverse events grade 3 or higher or having a serious adverse event | 6 months |
| difference of geriatric assessment score between day 1 and 3 month | day 1 and 3 months |
Countries
France, Monaco
Outcome results
None listed