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

July 29, 2020 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Hopital Sud
      • Angers, France
        • CHU Angers
      • Annecy, France
        • CH Annecy
      • Avignon, France
        • CH Henri Duffaut
      • Blois, France
        • CH BLOIS
      • Boulogne Sur Mer, France
        • CH Boulogne sur Mer
      • Corbeil Essonnes, France
        • CH Sud Francillien
      • Creteil, France
        • CHU Henri Mondor
      • Grenoble, France
        • CHU Albert Michallon
      • Le Chesnay, France
        • CH Versailles
      • Le Mans, France
        • CH du Mans
      • Lens, France
        • CH de Lens
      • Lille, France
        • Hôpital saint vincent de paul - Institut Catholique
      • Limoges, France
        • Chu Limoges
      • Lyon, France
        • CH Lyon sud
      • Marseille, France
        • Institut Paoli Calmette
      • Meaux, France
        • CH de Meaux
      • Nancy, France
        • CHU Brabois
      • Nantes, France
        • CHU Hôtel Dieu
      • Nice, France
        • Hôpital de L'Archet I
      • Paris, France
        • Hopital Cochin
      • Paris, France
        • Hopital St Louis
      • Perpignan, France
        • CH Saint Jean
      • Poitiers, France
        • CHU Poitiers
      • Pontoise, France
        • CH René Dubos
      • Rennes, France
        • Hôpital Pontchaillou
      • Rouen, France
        • Centre Henri Becquerel
      • Saint Malo, France
        • Ch St Malo
      • Toulouse, France
        • CHU Toulouse
      • Tours, France
        • Hôpital Bretonneau
  • Monaco
      • Monaco, Monaco
        • CH Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: research of disease-related factors
included in IPSS and IPSS-R, lactate dehydrogenase, ferritin level, transfusion- dependence, molecular markers as genes mutations
Other: research of comorbidities
HCT-Comorbidity Index, MDS-Comorbidity Index, Adult Comorbidity Evaluation-27, Cumulative Illness Rating Scale-G
Other: physical performance
Activities of Daily Living and physical performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IPPS score
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of patients who had adverse events grade 3 or higher or having a serious adverse event
Time Frame: 6 months
6 months
difference of geriatric assessment score between day 1 and 3 month
Time Frame: day 1 and 3 months
day 1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

National Cancer Institute, France

Investigators

  • Principal Investigator: Odile BEYNE-RAUZY, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2016

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14 7429 07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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