Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

NCT04178616 | Terminated

• 2 other identifiers: 2018_842019-A01083-54
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective monocentric study of patients with systemic sclerosis disease. 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

Conditions

Olfactory Disorders; Scleroderma

Outcome Measures

Primary Outcomes (1)

• Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points

  The European Test of Olfactory Capabilities is an olfactory test based on standardized odorants.A composite score evaluates the ability of the patients to define odors localisation and odors identification.The maximum global score is 32 points, the minimum is 0 point. The localisation ability score is rated from 0 to 16 points; The identification score is rated from 0 to 16 points. An hyposmia is defined by a global score strictly inferior to 27 points.

  once time, Baseline

Secondary Outcomes (8)

• Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points

  once time, Baseline

• Percentage of patients with an unilateral Lund Kennedy score of more than 3 points.

  once time, Baseline

• Measurement of systemic sclerosis disease activity with Medsger Score

  once time, Baseline

• Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score

  once time, Baseline

• Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score.

  once time, Baseline

Study Arms (1)

systemic sclerosis patients population

OTHER

All the patients with systemic sclerosis disease followed in day-care in a tertiary hospital are eligible to be enrolled in the study.

Diagnostic Test: olfactory testing with specific odorants (localisation and identification)

Interventions

olfactory testing with specific odorants (localisation and identification) DIAGNOSTIC_TEST

Olfactory testing : ETOC (European Test of Olfactory capabilities)

Also known as: nasofibroscopy to identify sinonasal mucosa diseases

systemic sclerosis patients population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and/or women
• With systemic sclerosis disease
• Patient willing to comply with all procedures of the study and its duration
• Social insured patients

You may not qualify if:

• Patient with medical history of chronic rhinosinusitis (CRS), previously known for olfactory disorders secondary to another etiology (skull base trauma, viral rhinosinusitis)
• 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…)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

Related Publications (2)

• 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.

  PMID: 25424576 BACKGROUND

• 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.

  PMID: 29444467 RESULT

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• David Launay, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is single-group epidemiologic study, without any control group.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: November 26, 2019
• Study Start: December 31, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

FR (1)