Eosinophilia Diagnosis

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Brief Title

Eosinophilia Diagnosis

Official Title

Algorithm for the Early Diagnosis and Treatment of Patients With Eosinophilia

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
    


Study Type

Interventional


Primary Outcome

Number of patients having correctly follow the diagnosis algorithm

Secondary Outcome

 Rate of diagnosis

Condition

Hypereosinophilic Syndrome

Intervention

Scheduled exams and diagnosis

Study Arms / Comparison Groups

 Algorithm
Description:  Eosinophilia is assessed following the diagnosis algorithm

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

53

Start Date

October 2015

Completion Date

November 2019

Primary Completion Date

September 2019

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Holy BEZANAHARY, +33(0)5 55 04 92 21, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02581514

Organization ID

I14028/EOSINOPHILIM


Responsible Party

Sponsor

Study Sponsor

University Hospital, Limoges


Study Sponsor

Holy BEZANAHARY, Principal Investigator, University Hospital, Limoges


Verification Date

June 2019