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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

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

Detailed Description:
  • 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 Design
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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Case Control
Time Perspective: Prospective
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

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Case group
Patient developing a first episode of infection since diagnosis of high-risk MDS (index case)
 Other: No intervention
Control group

Patient with no infection since diagnosis of MDS

Patient will be paired to index case by:

  • Hospital site
  • Age
  • Sexe Control patient is eligible if he has been seen in consultation within 15days before or after date of first infection of index case If matching fails, control patient can be found in another site and/or within 30days before or after date of first infection of index case
 Other: No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of infectious episode [ Time Frame: 12 months follow-up ]

Secondary Outcome Measures :
  1. severity of infectious episode [ Time Frame: 12 months follow-up ]
  2. Overall Survival (all-cause mortality) [ Time Frame: 12months follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with high-risk MDS (IPSS > 1,5)
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • MDS with IPSS >1.5
  • With a first infectious episode since the diagnosis of SMD of high risk (Case)
  • Unhurt of any infection and being able to be mated in the case index (Control)
  • Consulting or hospitalized in one of the services involved in the study during the period of inclusion

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Andrea Toma, MD, PhD andrea.toma@aphp.fr

Locations
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France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Laetitia Grégoire    01 49 81 41 64    Laetitia.gregoire@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Andrea Toma, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02905552     History of Changes
Other Study ID Numbers: NI13004
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myelodysplastic syndrome (myelodysplasia)
Infection
Risk Factors
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
 Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms