Myelodysplasic Syndromes and Risk Factors for Infection | NCT02905552

Studies
Myelodysplasic Syndromes and Risk Factors for Infection

NCT02905552

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Dec 21, 2016Estimated

Enrollment

320Estimated

Phase

Not provided

Conditions

Myelodysplastic Syndrome (MDS)
Infection
Risk Factors
IPSS High Risk

Interventions

No intervention

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Sep 14, 2016

First Submission Date that Met QC Criteria

Sep 16, 2016

First Posted Date

Sep 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2016

Last Update Posted Date

Dec 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		Case group Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of infectious episode		12 months follow-up

Secondary Outcomes

Measure	Description	Time Frame
severity of infectious episode		12 months follow-up
Overall Survival (all-cause mortality)		12months follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with high-risk MDS (IPSS > 1,5)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Toma, MD, PhD	Contact			andrea.toma@aphp.fr

Overall Officials

Name	Affiliation	Role
Andrea Toma, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henri Mondor Hospital	Recruiting	Créteil		94010	France

Condition Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes
D007239	Infections
D000754	Anemia, Refractory, with Excess of Blasts

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000753	Anemia, Refractory

Browse Leaves

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Browse Branches

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