PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Other: research of disease-related factorsOther: research of comorbiditiesOther: physical performance
- Registration Number
- NCT02689622
- Lead Sponsor
- University Hospital, Toulouse
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evaluation of disease prognostic factors research of disease-related factors Research of disease-related factors, research of comorbidities, geriatric assessment (Mini Mental Status Examination (MMSE), Geriatric Depression Scale-15, Mini Nutritional Assessment, Short Physical Performance Battery, grip strength, Fried criteria, Activities of Daily Living (ADL), Instrumental-ADL, G8, self-reported health status, quality of life Quality of Life Questionnaire-C30, Elderly Cancer Patients-14, EQ5D) at inclusion. At 3 months ADL and physical performance. Grade 3/4 toxicities and serious adverse events will be assessed during 6 months after inclusion (using NCI-COMMON TERMINOLOGY CRITERIA version 2.0) whatever treatment type (chemotherapy, supportive care). Evaluation of disease prognostic factors research of comorbidities Research of disease-related factors, research of comorbidities, geriatric assessment (Mini Mental Status Examination (MMSE), Geriatric Depression Scale-15, Mini Nutritional Assessment, Short Physical Performance Battery, grip strength, Fried criteria, Activities of Daily Living (ADL), Instrumental-ADL, G8, self-reported health status, quality of life Quality of Life Questionnaire-C30, Elderly Cancer Patients-14, EQ5D) at inclusion. At 3 months ADL and physical performance. Grade 3/4 toxicities and serious adverse events will be assessed during 6 months after inclusion (using NCI-COMMON TERMINOLOGY CRITERIA version 2.0) whatever treatment type (chemotherapy, supportive care). Evaluation of disease prognostic factors physical performance Research of disease-related factors, research of comorbidities, geriatric assessment (Mini Mental Status Examination (MMSE), Geriatric Depression Scale-15, Mini Nutritional Assessment, Short Physical Performance Battery, grip strength, Fried criteria, Activities of Daily Living (ADL), Instrumental-ADL, G8, self-reported health status, quality of life Quality of Life Questionnaire-C30, Elderly Cancer Patients-14, EQ5D) at inclusion. At 3 months ADL and physical performance. Grade 3/4 toxicities and serious adverse events will be assessed during 6 months after inclusion (using NCI-COMMON TERMINOLOGY CRITERIA version 2.0) whatever treatment type (chemotherapy, supportive care).
- Primary Outcome Measures
Name Time Method IPPS score 1 year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (31)
Hôpital Sud
🇫🇷Amiens, France
CH Henri Duffaut
🇫🇷Avignon, France
CH Boulogne sur mer
🇫🇷Boulogne Sur Mer, France
CHU Albert Michallon
🇫🇷Grenoble, France
CH de Lens
🇫🇷Lens, France
CHU Limoges
🇫🇷Limoges, France
CH Versailles
🇫🇷Le Chesnay, France
Hôpital COCHIN
🇫🇷Paris, France
Hôpital de l'archet I
🇫🇷Nice, France
Chu Brabois
🇫🇷Nancy, France
Ch Lyon Sud
🇫🇷Lyon, France
Institut Paoli Calmette
🇫🇷Marseille, France
Hôpital St Louis
🇫🇷Paris, France
Centre Henri Becquerel
🇫🇷Rouen, France
CH St Malo
🇫🇷Saint Malo, France
CH du Mans
🇫🇷Le Mans, France
CHU Henri Mondor
🇫🇷Creteil, France
Chu Angers
🇫🇷Angers, France
CH Sud Francillien
🇫🇷Corbeil Essonnes, France
Hôpital saint vincent de paul - Institut Catholique
🇫🇷Lille, France
CH de Meaux
🇫🇷Meaux, France
Chu Hotel Dieu
🇫🇷Nantes, France
CH Saint Jean
🇫🇷Perpignan, France
Hôpital Bretonneau
🇫🇷Tours, France
CHU Toulouse
🇫🇷Toulouse, France
CH Annecy
🇫🇷Annecy, France
CH Blois
🇫🇷Blois, France
CHU Poitiers
🇫🇷Poitiers, France
Hôpital Pontchaillou
🇫🇷Rennes, France
CH René Dubos
🇫🇷Pontoise, France
CH Princesse Grâce
🇲🇨Monaco, Monaco