Myelodysplasic Syndromes and Risk Factors for Infection (MYRIFIC)
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|ClinicalTrials.gov Identifier: NCT02905552|
Recruitment Status : Unknown
Verified December 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : September 19, 2016
Last Update Posted : December 21, 2016
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia.
The risk of leukemic transformation is estimated by the score IPSS (International Prognostic Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of leukemic transformation (IPSS=1,5).
Besides the risk of leukemic transformation, MDS much be complicated of infections which could be life-threatening.
The risk of developing first infection after the diagnosis of MDS of high risk is probably influenced by anamnestic (disease duration, comorbidities), clinical (veinous central catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin) and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions, anti-infectious preventive treatment) factors. Their identification will allow for improved targeting of the population which is is likely to benefit from anti-infective prophylaxis Primary objective is to identify risk factors associated with first acute episode of infection in patients with MDS, by comparing index cases and matched control cases who did not develop infection episode since diagnosis.
Secondary objectives are to explore nature and severity of infectious episodes, number of recurrences during 1 year of follow up and survival at 6 and 12 months
|Condition or disease||Intervention/treatment|
|Myelodysplastic Syndrome (MDS) Infection Risk Factors IPSS High Risk||Other: No intervention|
- 160 couples (Case / Control)
- Pairing according to age (+/- 5 years), sex and medical consultation date (+/-15 days)
- Follow up at M3, M6, M9 and M12
- Study duration : 24 months
- Inclusion duration : 12 months
|Study Type :||Observational|
|Estimated Enrollment :||320 participants|
|Observational Model:||Case Control|
|Official Title:||Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2018|
Patient developing a first episode of infection since diagnosis of high-risk MDS (index case)
Other: No intervention
Patient with no infection since diagnosis of MDS
Patient will be paired to index case by:
Other: No intervention
- Occurrence of infectious episode [ Time Frame: 12 months follow-up ]
- severity of infectious episode [ Time Frame: 12 months follow-up ]
- Overall Survival (all-cause mortality) [ Time Frame: 12months follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905552
|Contact: Andrea Toma, MD, PhDemail@example.com|
|Henri Mondor Hospital||Recruiting|
|Creteil, France, 94010|
|Contact: Laetitia Grégoire 01 49 81 41 64 Laetitia.firstname.lastname@example.org|
|Principal Investigator:||Andrea Toma, MD, PhD||Assistance Publique - Hôpitaux de Paris|