Ignite Creation Date:
2024-05-06 @ 8:10 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02689622
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2015-12-14
Brief Title:
PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDICTOR
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 patientscare 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
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 patientscare 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None