Study of the Level of a Protein Which Could Predict the D... | NCT02823132

Studies
Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia

NCT02823132

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Jul 6, 2016Estimated

Enrollment

134Actual

Phase

Not provided

Conditions

Acute Leukemia
Invasive Fungal Infection

Interventions

blood sample

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Jun 2015Actual

Completion Date

Not provided

First Submitted Date

Jun 29, 2016

First Submission Date that Met QC Criteria

Jul 5, 2016

First Posted Date

Jul 6, 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

Jul 5, 2016

Last Update Posted Date

Jul 6, 2016Estimated

Description Module

Brief Summary

The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.

Detailed Description

Not provided

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

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients who develop a fungal infection			Biological: blood sample
patients without fungal infection			Biological: blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Biological		patients who develop a fungal infection patients without fungal infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia		1st day of the period of aplasia

Secondary Outcomes

Measure	Description	Time Frame
Serum levels of MBL during an episode of aplasia for both groups of patients studied		Every day except Saturday and Sunday for roughly 3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

persons who have provided written consent
Patients with national health insurance cover
Patients with malignant hemopathy who have been treated with chemotherapy able to induce profound neutropenia (PN < 500 / mm3) lasting more than 10 days.
Patients with malignant hemopathy who have received an autologous bone marrow graft
Patients with severe idiopathic medullar aplasia (PN < 500 / mm3) who need to be hospitalized for at least 10 consecutive days (with or without treatment with immunosuppressants)

Exclusion Criteria:

Patients who have received an bone marrow PSC allograft (as such patients have a risk of aspergillosis, which appears in most cases after medullar recovery; they will not be included in the study).
Patients who have received an autologous PSC graf (as the duration of neutropenia is in most cases less than 10 days).
Patients whose neutropenia, retrospectively assessed, lasted less than 10 days.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with acute leukemia

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire		Dijon		21079	France

Condition Browse Module

MeSH Terms

ID	Term
D000072742	Invasive Fungal Infections

Ancestor Terms

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided