Eosinophilia Diagnosis

NCT02581514 | Unknown

• 1 other identifier: I14028/EOSINOPHILIM
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypereosinophilic Syndrome

Keywords

decision algorithm

Outcome Measures

Primary Outcomes (1)

• Number of patients having correctly follow the diagnosis algorithm

  This outcome measure how many patients have correctly followed the diagnosis algorithm

  5 months

Secondary Outcomes (3)

• Rate of diagnosis

  5 months

• Assess the time to diagnosis

  5 months

• Description of diagnosis

  5 months

Study Arms (1)

Algorithm

EXPERIMENTAL

Eosinophilia is assessed following the diagnosis algorithm

Other: Scheduled exams and diagnosis

Interventions

Scheduled exams and diagnosis OTHER

Scheduled exams and diagnosis circuit as imposed by the algorithm

Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Patient affiliated or beneficiary of a social security system
• Patient who signed the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Médecine Interne A

Limoges, 87000, France

RECRUITING

MeSH Terms

Conditions

Hypereosinophilic Syndrome

Condition Hierarchy (Ancestors)

Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Holy BEZANAHARY

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holy BEZANAHARY

CONTACT

+33(0)5 55 04 92 21; h.bezanahary@wanadoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

FR (1)