Survey of Patients With Idiopathic Orbital Inflammation Syndrome

NCT ID: NCT01443000

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-03

Study Completion Date

2017-06-03

Brief Summary

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The purpose of this study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome.

Detailed Description

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Idiopathic orbital inflammatory syndrome (IOIS) is a heterogeneous group of disorders characterised by orbital inflammation without any identifiable local or systemic causes. It is a rare clinical entity and a diagnosis of exclusion. Lymphomas, thyroid eye diseases or systemic diseases can have similar presentation and so, a histopathological diagnosis is considered important. IOIS is a difficult condition to treat. Compilation of reported small series of patients with IOIS suggested that they require multiple systemic immunosuppressant drugs and radiotherapy. Recently, a large monocentric study including patients with biopsy proven IOIS showed that up to 40% of them can relapse. Their clinical and pathological features did not correlate with treatments outcomes. The investigators decide therefore to conduct a multicentric retro/ prospective study to determine clinical features, histopathology and treatment outcomes of French patients with IOIS.

Conditions

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Orbital Ischemic Syndrome Orbital Pseudotumor

Keywords

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Observational study IOIS Orbital Pseudotumor Outcome Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with biopsy proven IOIS or presumed IOIS
* Patients with chronic IOS
* Patient with inaugural IOIS or being treated for IOIS

* Patients with systemic disease-associated IOIS
* Incomplete follow-up of patients treated for IOIS
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien ABAD, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service de Médecine interne - Hôpital Avicenne

Bobigny, , France

Site Status

Countries

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France

Other Identifiers

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2010-A00512-37

Identifier Type: OTHER

Identifier Source: secondary_id

NI08014

Identifier Type: -

Identifier Source: org_study_id