PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.

Myelodysplastic Syndromes Clinical Trial

— PREDICTOR  

Official title:

Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689622
• Other study ID #: 14 7429 07
• Status: Completed
• Phase: N/A
• Start date: April 20, 2016
• Est. completion date: January 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 2020
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	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	Creteil
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	Saint Malo
France	CHU Toulouse	Toulouse
France	Hôpital Bretonneau	Tours
Monaco	CH Princesse Grâce	Monaco

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	National Cancer Institute, France

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPPS score		1 year
Secondary	percentage of patients who had adverse events grade 3 or higher or having a serious adverse event		6 months
Secondary	difference of geriatric assessment score between day 1 and 3 month		day 1 and 3 months