Clinical trial NCT02689622: PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
Official title: Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myelodysplastic Syndromes
Keywords: Hematology
Elderly
High Risk Myelodysplastic Syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2016-02-24
Enrollment: 157
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: IPPS score
timeFrame: 1 year
Secondary outcomes:
measure: percentage of patients who had adverse events grade 3 or higher or having a serious adverse event
timeFrame: 6 months
measure: difference of geriatric assessment score between day 1 and 3 month
timeFrame: day 1 and 3 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hôpital Sud
city: Angers
country: France
facility: Chu Angers
city: Annecy
country: France
facility: CH Annecy
city: Avignon
country: France
facility: CH Henri Duffaut
city: Blois
country: France
facility: CH Blois
city: Boulogne Sur Mer
country: France
facility: CH Boulogne sur mer
city: Corbeil Essonnes
country: France
facility: CH Sud Francillien
city: Creteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU Albert Michallon
city: Le Chesnay
country: France
facility: CH Versailles
city: Le Mans
country: France
facility: CH du Mans
city: Lens
country: France
facility: CH de Lens
city: Lille
country: France
facility: Hôpital saint vincent de paul - Institut Catholique
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Ch Lyon Sud
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Meaux
country: France
facility: CH de Meaux
city: Nancy
country: France
facility: Chu Brabois
city: Nantes
country: France
facility: Chu Hotel Dieu
city: Nice
country: France
facility: Hôpital de l'archet I
city: Paris
country: France
facility: Hôpital COCHIN
city: Paris
country: France
facility: Hôpital St Louis
city: Perpignan
country: France
facility: CH Saint Jean
city: Poitiers
country: France
facility: CHU Poitiers
city: Pontoise
country: France
facility: CH René Dubos
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Malo
country: France
facility: CH St Malo
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: Hôpital Bretonneau
city: Monaco
country: Monaco
facility: CH Princesse Grâce
Study officials:
affiliation: University Hospital, Toulouse
name: Odile BEYNE-RAUZY, MD
role: PRINCIPAL_INVESTIGATOR
References: