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Trial record 15 of 87 for:    "Hypereosinophilic syndrome"

Eosinophilia Diagnosis (EOSINOPHILIM)

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ClinicalTrials.gov Identifier: NCT02581514
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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.


Condition or disease Intervention/treatment Phase
Hypereosinophilic Syndrome Other: Scheduled exams and diagnosis Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Algorithm for the Early Diagnosis and Treatment of Patients With Eosinophilia
Study Start Date : October 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : November 2018


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




Primary Outcome Measures :
  1. Number of patients having correctly follow the diagnosis algorithm [ Time Frame: 5 months ]
    This outcome measure how many patients have correctly followed the diagnosis algorithm


Secondary Outcome Measures :
  1. Rate of diagnosis [ Time Frame: 5 months ]
    Evaluate the rate of diagnosis using our diagnosis algorithm

  2. Assess the time to diagnosis [ Time Frame: 5 months ]
    Assess the time to diagnosis

  3. Description of diagnosis [ Time Frame: 5 months ]
    To compare the diagnosis found in our study to the published cohort.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581514


Contacts
Contact: Holy BEZANAHARY +33(0)5 55 04 92 21 h.bezanahary@wanadoo.fr

Locations
France
Médecine Interne A Recruiting
Limoges, France, 87000
Contact: Holy BEZANAHARY, MD       holy.bezanahary@chu-limoges.fr   
Principal Investigator: Holy BEZANAHARY         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Holy BEZANAHARY University Hospital, Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02581514     History of Changes
Other Study ID Numbers: I14028/EOSINOPHILIM
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Limoges:
decision algorithm

Additional relevant MeSH terms:
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases