Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
NCT ID: NCT04178616
Last Updated: 2020-11-19
Study Results
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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TERMINATED
NA
59 participants
INTERVENTIONAL
2019-12-31
2020-03-13
Brief Summary
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The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease.
The secondary outcomes are:
* To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients.
* To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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systemic sclerosis patients population
All the patients with systemic sclerosis disease followed in day-care in a tertiary hospital are eligible to be enrolled in the study.
olfactory testing with specific odorants (localisation and identification)
Olfactory testing : ETOC (European Test of Olfactory capabilities)
Interventions
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olfactory testing with specific odorants (localisation and identification)
Olfactory testing : ETOC (European Test of Olfactory capabilities)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With systemic sclerosis disease
* Patient willing to comply with all procedures of the study and its duration
* Social insured patients
Exclusion Criteria
* Past history of sinonasal surgery
* Patient unable to receive informed information
* Refusal to sign the consent form
* Unwillingness or inability to follow the study procedures, in the opinion of the investigator
* Person deprived of the liberty
* Non-coverage by the social security insurance
* Person benefiting from a system of legal protection (guardianship…)
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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David Launay, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hop Claude Huriez Chu Lille
Lille, , France
Countries
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References
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Amital H, Agmon-Levin N, Shoenfeld N, Arnson Y, Amital D, Langevitz P, Balbir Gurman A, Shoenfeld Y. Olfactory impairment in patients with the fibromyalgia syndrome and systemic sclerosis. Immunol Res. 2014 Dec;60(2-3):201-7. doi: 10.1007/s12026-014-8573-5.
Bombini MF, Peres FA, Lapa AT, Sinicato NA, Quental BR, Pincelli ASM, Amaral TN, Gomes CC, Del Rio AP, Marques-Neto JF, Costallat LTL, Fernandes PT, Cendes F, Rittner L, Appenzeller S. Olfactory function in systemic lupus erythematosus and systemic sclerosis. A longitudinal study and review of the literature. Autoimmun Rev. 2018 Apr;17(4):405-412. doi: 10.1016/j.autrev.2018.02.002. Epub 2018 Feb 11.
Other Identifiers
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2019-A01083-54
Identifier Type: OTHER
Identifier Source: secondary_id
2018_84
Identifier Type: -
Identifier Source: org_study_id