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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02905552
Other study ID # NI13004
Secondary ID
Status Recruiting
Phase N/A
First received September 14, 2016
Last updated December 20, 2016
Start date September 2016
Est. completion date September 2018

Study information

Verified date December 2016
Source Assistance Publique - Hôpitaux de Paris
Contact Andrea Toma, MD, PhD
Email andrea.toma@aphp.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date September 2018
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Other:
No intervention


Locations

Country Name City State
France Henri Mondor Hospital Creteil

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of infectious episode 12 months follow-up No
Secondary severity of infectious episode 12 months follow-up No
Secondary Overall Survival (all-cause mortality) 12months follow-up No
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