Shulman Fasciitis Prevalence Study in Alsace

Shulman Fasciitis Clinical Trial

— SHULMAN  

Official title:

Shulman Fasciitis Prevalence Study in Alsace

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829112
• Other study ID #: 6177
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2016
• Last updated: April 25, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: April 2017
• Source: University Hospital, Strasbourg, France
• Contact: Jean SIBILIA, MD, PhD
• Phone: 33 (0)3 88 12 79 54
• Email: jean.sibilia[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the clinic, confirmed by MRI and confirmed by histology, there really no published diagnostic criteria validated for this rare disease. The low number of cases reported in the literature reflects the difficulty of studying the epidemiology of this disease, to establish and evaluate therapeutic strategies and to assess prognosis. Work on this subject are few. To our knowledge, no study has previously used to estimate the incidence and prevalence of this disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in 2016 by a study "capture-recapture" using several independent sources of identification of cases in order to have recent epidemiological data and learn more about this disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged over 18 years

• Patients suffering from fasciitis Shulmande and living in Alsace at 1 January 2016

Exclusion Criteria:

• refusal to participate in the study

Related Conditions & MeSH terms

• Fasciitis
• Shulman Fasciitis

Locations

Country	Name	City	State
France	Service de rhumatologie, Les Hôpitaux Universitaires de Strasbourg, Centre national de référence " des maladies auto-immunes rares "	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of the prevalence of Shulman fasciitis in Alsace, the calculation will be carried out using the numerator of all the cases identified and in the denominator the general population (Alsatian population of both sexes)		all living patients in Alsace from 1 January 2016 to december 2016