Eosinophilia Diagnosis (EOSINOPHILIM)
Primary Purpose
Hypereosinophilic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scheduled exams and diagnosis
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypereosinophilic Syndrome focused on measuring decision algorithm
Eligibility Criteria
Inclusion Criteria:
Patient having one of the three following criteria:
- hypereosinophilia> 1500 / mm3, checked on at least two samples (interval between 2 samples at the discretion of the clinician)
- or hypereosinophilia> 500 cells / mm3 and organ damage with infiltration NCB proven by pathological examination,
- or hypereosinophilia> 500 cells / mm3 and found consistently for at least six months (present on all controls carried out before inclusion).
- Patient affiliated or beneficiary of a social security system
- Patient who signed the informed consent
Exclusion Criteria:
- Patient with solid tumors known (under chemotherapy or planned)
- Patient unable to understand or to adhere to the Protocol
- Patient unable to give consent
- Pregnant or breastfeeding women
- Patient already participating in an interventional trial
Sites / Locations
- Médecine Interne ARecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Algorithm
Arm Description
Eosinophilia is assessed following the diagnosis algorithm
Outcomes
Primary Outcome Measures
Number of patients having correctly follow the diagnosis algorithm
This outcome measure how many patients have correctly followed the diagnosis algorithm
Secondary Outcome Measures
Rate of diagnosis
Evaluate the rate of diagnosis using our diagnosis algorithm
Assess the time to diagnosis
Assess the time to diagnosis
Description of diagnosis
To compare the diagnosis found in our study to the published cohort.
Full Information
NCT ID
NCT02581514
First Posted
October 19, 2015
Last Updated
June 4, 2019
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT02581514
Brief Title
Eosinophilia Diagnosis
Acronym
EOSINOPHILIM
Official Title
Algorithm for the Early Diagnosis and Treatment of Patients With Eosinophilia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Eosinophilia, defined by a blood eosinophil granulocytes rate greater than 500 / mm3, is frequently encountered in internal medicine.
Its causes are varied: atopy, drug allergies, parasitic infections, autoimmune diseases and solid neoplasias. Over 200 etiologies have been reported, some difficult to diagnose and can be life-threatening Eosinophilia can be a diagnostic dilemma, as the etiologies are extensive and varied.
The aim of this study is to assess the feasibility of a diagnostic approach based on a decision algorithm in a group of patients with eosinophilia.
We assume that a procedure with a hierarchy of additional tests would increase the frequency of diagnosed cases while decreasing the time to diagnosis.
This procedure defined by an algorithm would even reduce the number of tests necessary to reach a diagnosis.
Detailed Description
Eosinophilia, defined by a blood eosinophil granulocytes rate greater than 500 / mm3, is frequently encountered in internal medicine.
Its causes are varied: atopy, drug allergies, parasitic infections, autoimmune diseases and solid neoplasias. Over 200 etiologies have been reported, some difficult to diagnose and can be life-threatening
Eosinophilia can be a diagnostic dilemma, as the etiologies are extensive and varied.
The aim of this study is to assess the feasibility of a diagnostic approach based on a decision algorithm in a group of patients with eosinophilia.
The contribution to the diagnosis of a hierarchical strategy for prescribing additional tests , based on clinical examination as well as some simple diagnostic tests, has never been evaluated
We assume that a procedure with a hierarchy of additional tests would increase the frequency of diagnosed cases while decreasing the time to diagnosis.
This procedure defined by an algorithm would even reduce the number of tests necessary to reach a diagnosis.
All types of patients are tacked into account: those coming from the university hospital, referred by general practitioners or by other hospitals.
In addition we address the internal medicine patients ,but also those of Hematology and Infectious Diseases. A comparison of these various groups would be relevant, since disorders that may be different.
Once enrolled, the patient is drived by the investigator through the various steps and exams imposed by the algorithm.
Indeed, during 5 months (Day1 5, 43, 71 , 85 , 99 ,113 and month 5), patient is asked to comply to the various exams and assessment imposed by the algorithm and that should lead to a diagnosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypereosinophilic Syndrome
Keywords
decision algorithm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Algorithm
Arm Type
Experimental
Arm Description
Eosinophilia is assessed following the diagnosis algorithm
Intervention Type
Other
Intervention Name(s)
Scheduled exams and diagnosis
Intervention Description
Scheduled exams and diagnosis circuit as imposed by the algorithm
Primary Outcome Measure Information:
Title
Number of patients having correctly follow the diagnosis algorithm
Description
This outcome measure how many patients have correctly followed the diagnosis algorithm
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Rate of diagnosis
Description
Evaluate the rate of diagnosis using our diagnosis algorithm
Time Frame
5 months
Title
Assess the time to diagnosis
Description
Assess the time to diagnosis
Time Frame
5 months
Title
Description of diagnosis
Description
To compare the diagnosis found in our study to the published cohort.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient having one of the three following criteria:
hypereosinophilia> 1500 / mm3, checked on at least two samples (interval between 2 samples at the discretion of the clinician)
or hypereosinophilia> 500 cells / mm3 and organ damage with infiltration NCB proven by pathological examination,
or hypereosinophilia> 500 cells / mm3 and found consistently for at least six months (present on all controls carried out before inclusion).
Patient affiliated or beneficiary of a social security system
Patient who signed the informed consent
Exclusion Criteria:
Patient with solid tumors known (under chemotherapy or planned)
Patient unable to understand or to adhere to the Protocol
Patient unable to give consent
Pregnant or breastfeeding women
Patient already participating in an interventional trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holy BEZANAHARY
Phone
+33(0)5 55 04 92 21
Email
h.bezanahary@wanadoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holy BEZANAHARY
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Médecine Interne A
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holy BEZANAHARY, MD
Email
holy.bezanahary@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Holy BEZANAHARY
12. IPD Sharing Statement
Learn more about this trial
Eosinophilia Diagnosis
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