PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
PREDICTOR
Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
1 other identifier
interventional
157
2 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2016
CompletedStudy Start
First participant enrolled
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJuly 30, 2020
July 1, 2020
2.8 years
December 14, 2015
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IPPS score
1 year
Secondary Outcomes (2)
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
Study Arms (1)
Evaluation of disease prognostic factors
EXPERIMENTALResearch 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).
Interventions
included in IPSS and IPSS-R, lactate dehydrogenase, ferritin level, transfusion- dependence, molecular markers as genes mutations
HCT-Comorbidity Index, MDS-Comorbidity Index, Adult Comorbidity Evaluation-27, Cumulative Illness Rating Scale-G
Activities of Daily Living and physical performance
Eligibility Criteria
You may qualify if:
- Diagnosis of HR-MDS inferior to 6 weeks,
- IPSS superior to 1 (intermediate 2 and high risk IPSS categories),
- Social system affiliation,
- Informed consent signed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- National Cancer Institute, Francecollaborator
Study Sites (31)
Hôpital Sud
Amiens, France
Chu Angers
Angers, France
CH Annecy
Annecy, France
CH Henri Duffaut
Avignon, France
CH Blois
Blois, France
CH Boulogne sur mer
Boulogne-sur-Mer, France
CH Sud Francillien
Corbeil-Essonnes, France
CHU Henri Mondor
Créteil, France
CHU Albert Michallon
Grenoble, France
CH Versailles
Le Chesnay, France
CH du Mans
Le Mans, France
CH de Lens
Lens, France
Hôpital saint vincent de paul - Institut Catholique
Lille, France
CHU Limoges
Limoges, France
Ch Lyon Sud
Lyon, France
Institut Paoli Calmette
Marseille, France
CH de Meaux
Meaux, France
Chu Brabois
Nancy, France
Chu Hotel Dieu
Nantes, France
Hôpital de l'archet I
Nice, France
Hôpital COCHIN
Paris, France
Hôpital St Louis
Paris, France
CH Saint Jean
Perpignan, France
CHU Poitiers
Poitiers, France
CH René Dubos
Pontoise, France
Hôpital Pontchaillou
Rennes, France
Centre Henri Becquerel
Rouen, France
CH St Malo
St-Malo, France
CHU Toulouse
Toulouse, France
Hôpital Bretonneau
Tours, France
CH Princesse Grâce
Monaco, Monaco
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odile BEYNE-RAUZY, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2015
First Posted
February 24, 2016
Study Start
April 20, 2016
Primary Completion
January 31, 2019
Study Completion
January 1, 2020
Last Updated
July 30, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share