RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age

NCT ID: NCT06273748

Last Updated: 2024-03-08

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

RECRUITING

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-10

Study Completion Date

2032-05-02

Brief Summary

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Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases

Detailed Description

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Conditions

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Uveitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of non-infectious chronic uveitis before the age of 16;
* signed informed consent form.

Exclusion Criteria

* Patients with a diagnosis of infectious uveitis
* history of malignant pathology,
* history of demyelinating pathology,
* history of cerebral vasculitis
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meyer Children's Hospital IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Gabriele Simonini

Head of Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

- ATTIKON General Hospital

Athens, , Greece

Site Status RECRUITING

Meyer Children's Hospital IRCCS

Florence, Firenze, Italy

Site Status RECRUITING

Ospedale Spedali Civili di Brescia

Brescia, , Italy

Site Status NOT_YET_RECRUITING

IRCCS materno infantile Burlo Garofolo

Trieste, , Italy

Site Status RECRUITING

Countries

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United States Greece Italy

Central Contacts

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Gabriele Simonini

Role: CONTACT

3297973141

Facility Contacts

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Sheila Angels-Han

Role: primary

Lampros Fotis

Role: primary

Gabriele Simonini

Role: primary

Marco Cattalini

Role: primary

Serena Pastore

Role: primary

Other Identifiers

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RChildUV

Identifier Type: -

Identifier Source: org_study_id

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