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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02689622 |
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Date of registration:
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14/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.
PREDICTOR |
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Scientific title:
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Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes. |
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Date of first enrolment:
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April 20, 2016 |
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Target sample size:
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157 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02689622 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Monaco
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Contacts
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Name:
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Odile BEYNE-RAUZY, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Key inclusion & exclusion criteria
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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.
Age minimum:
70 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myelodysplastic Syndromes
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Intervention(s)
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Other: physical performance
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Other: research of comorbidities
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Other: research of disease-related factors
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Primary Outcome(s)
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IPPS score
[Time Frame: 1 year]
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Secondary Outcome(s)
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difference of geriatric assessment score between day 1 and 3 month
[Time Frame: day 1 and 3 months]
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percentage of patients who had adverse events grade 3 or higher or having a serious adverse event
[Time Frame: 6 months]
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Secondary ID(s)
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14 7429 07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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