- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02829112
Shulman Fasciitis Prevalence Study in Alsace (SHULMAN)
April 25, 2017 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jean SIBILIA, MD, PhD
- Phone Number: 33 (0)3 88 12 79 54
- Email: jean.sibilia@chru-strasbourg.fr
Study Contact Backup
- Name: Lionel Spielmann, MD
- Phone Number: 33 (0)3 88 12 79 54
- Email: lionel.spielmann@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service de rhumatologie, Les Hôpitaux Universitaires de Strasbourg, Centre national de référence " des maladies auto-immunes rares "
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Contact:
- Jean SIBILIA, MD, PhD
- Phone Number: 03 88 12 79 54
- Email: jean.sibilia@chru-strasbourg.fr
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Contact:
- Lionel Spielmann, MD
- Phone Number: 03 88 12 79 54
- Email: lionel535@hotmail.com
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Sub-Investigator:
- Mickael Schaeffer
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Sub-Investigator:
- Jean-François Kleinmann
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients suffering from fasciitis Shulmande and living in Alsace at 1 January 2016
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
Time Frame: all living patients in Alsace from 1 January 2016 to december 2016
|
all living patients in Alsace from 1 January 2016 to december 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
June 16, 2016
First Submitted That Met QC Criteria
July 7, 2016
First Posted (Estimate)
July 12, 2016
Study Record Updates
Last Update Posted (Actual)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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