PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
NCT ID: NCT02689622
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
157 participants
INTERVENTIONAL
2016-04-20
2020-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Evaluation of disease prognostic 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).
research of disease-related factors
included in IPSS and IPSS-R, lactate dehydrogenase, ferritin level, transfusion- dependence, molecular markers as genes mutations
research of comorbidities
HCT-Comorbidity Index, MDS-Comorbidity Index, Adult Comorbidity Evaluation-27, Cumulative Illness Rating Scale-G
physical performance
Activities of Daily Living and physical performance
Interventions
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research of disease-related factors
included in IPSS and IPSS-R, lactate dehydrogenase, ferritin level, transfusion- dependence, molecular markers as genes mutations
research of comorbidities
HCT-Comorbidity Index, MDS-Comorbidity Index, Adult Comorbidity Evaluation-27, Cumulative Illness Rating Scale-G
physical performance
Activities of Daily Living and physical performance
Eligibility Criteria
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Inclusion Criteria
* No treatment received before inclusion,
* IPSS superior to 1 (intermediate 2 and high risk IPSS categories),
* Social system affiliation,
* Informed consent signed.
Exclusion Criteria
* IPSS inferior or egal 1 (low or intermediate 1 IPSS),
* Concomitant investigational trial participation, which could interfere,
* Patients under legal protection.
70 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Odile BEYNE-RAUZY, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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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
Countries
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Other Identifiers
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14 7429 07
Identifier Type: -
Identifier Source: org_study_id
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