Interest of ß 1-3 D Glucan Assays in Screening for the On... | NCT02851680

Studies
Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.

NCT02851680

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Aug 3, 2016Estimated

Enrollment

476Actual

Phase

Not Applicable

Conditions

Invasive Fungal Infections

Interventions

blood samples

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

Sep 2014

Primary Completion Date

May 2015Actual

Completion Date

Not provided

First Submitted Date

Jul 28, 2016

First Submission Date that Met QC Criteria

Jul 28, 2016

First Posted Date

Aug 2, 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

Aug 2, 2016

Last Update Posted Date

Aug 3, 2016Estimated

Description Module

Brief Summary

In the context of screening for infectious fungal diseases in patients with malignant haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate the performance of an already commercialized but little used serum screening test (Fungitell® test) and to determine its place in the management strategy for invasive aspergillosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

476Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fongitell test	Experimental		Biological: blood samples
serum galactomannan	Active Comparator		Biological: blood samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood samples	Biological		Fongitell test serum galactomannan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of the results of the 1-3 ß D glucan serum assay obtained with the Fungitell® test and the test currently used (in terms of specificity, sensitivity, negative predictive value and positive predictive value		8 to 10 assays over 4 to 5 weeks of hospitalization

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have been informed about the study
Patients over 18 years
patients with acute myeloblastic leukaemia (AML) or lymphoblastic leukaemia (ALL) who have undergone cytotoxic chemotherapy with curative intent

Exclusion Criteria:

Adults under guardianship
Patients without national health insurance cover
Pregnant or breast-feeding women
allografts and autografts of Haematopoietic Stem Cells (HSC)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU Dijon Bourgogne		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