Eosinophilia Diagnosis (EOSINOPHILIM)

Algorithm for the Early Diagnosis and Treatment of Patients With Eosinophilia

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.

Study Overview

• Status: Unknown
• Conditions: Hypereosinophilic Syndrome
• Intervention / Treatment: Other: Scheduled exams and 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

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holy BEZANAHARY; Phone Number: +33(0)5 55 04 92 21; Email: h.bezanahary@wanadoo.fr

Study Locations

• France
  • Limoges, France, 87000
    • Recruiting
    • Médecine Interne A
    • Contact: Holy BEZANAHARY, MD; Email: holy.bezanahary@chu-limoges.fr
    • Principal Investigator: Holy BEZANAHARY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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).
2. Patient affiliated or beneficiary of a social security system
3. Patient who signed the informed consent

Exclusion Criteria:

1. Patient with solid tumors known (under chemotherapy or planned)
2. Patient unable to understand or to adhere to the Protocol
3. Patient unable to give consent
4. Pregnant or breastfeeding women
5. Patient already participating in an interventional trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Algorithm; Eosinophilia is assessed following the diagnosis algorithm	Other: Scheduled exams and diagnosis; Scheduled exams and diagnosis circuit as imposed by the algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients having correctly follow the diagnosis algorithm	This outcome measure how many patients have correctly followed the diagnosis algorithm	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of diagnosis	Evaluate the rate of diagnosis using our diagnosis algorithm	5 months
Assess the time to diagnosis	Assess the time to diagnosis	5 months
Description of diagnosis	To compare the diagnosis found in our study to the published cohort.	5 months

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Holy BEZANAHARY, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (ESTIMATE): October 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: decision algorithm
• Additional Relevant MeSH Terms: Hematologic Diseases; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome
• Other Study ID Numbers: I14028/EOSINOPHILIM