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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02689622
Other study ID # 14 7429 07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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