Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma (SCLEROLF)

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

Study Overview

• Status: Terminated
• Conditions: Scleroderma; Olfactory Disorders
• Intervention / Treatment: Diagnostic test: olfactory testing with specific odorants (localisation and identification)

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Claude Huriez Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria :

• 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…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Diagnostic test: olfactory testing with specific odorants (localisation and identification); Olfactory testing : ETOC (European Test of Olfactory capabilities); Other Names: nasofibroscopy to identify sinonasal mucosa diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 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 anosmia is defined by an global score strictly inferior to 10 points.	once time, Baseline
Percentage of patients with an unilateral Lund Kennedy score of more than 3 points.	Evaluation of nasal mucosa inflammation status is based on Lund-Kennedy endoscopic score. The Lund Kennedy score ranged from 0 to 8 points for each nasal fossa. It evaluates oedema, discharge, the presence of polyps and crusting, that can be seen through nasal fibroscopy. A score strictly under 3 points on each side is considered as non pathologic whereas a score equal or over 3 points on each side is pathological. A higher score means a worse outcome.	once time, Baseline
Measurement of systemic sclerosis disease activity with Medsger Score	Medsger Score estimates disease involvement of each organ (heart, vessels, skin, brain, kidney, gut, muscle, joint and loss of weight,) ranging from 0 to 4 (0: normal, 1: mild, 2: moderate, 3: severe, 4: terminal). The score ranges from 0 to 36 points.A higher score means a worse outcome.	once time, Baseline
Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score	The ETOC score ranges from 0 to 32 points ( as previously described ).A higher score means a better outcome. Medsger score ranges from 0 to 36 points. A higher score means a worse outcome.	once time, Baseline
Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score.	The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome. The Rodnan score measured skin thickness (0 : normal, 1 : mild, 2: moderate, 3: severe) on 17 different sites. A global score between 0 point to 51 points is established.A higher score means a worse outcome	once time, Baseline
Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score	The ETOC score ranges from 0 to 32 points (as previously described ). A higher score means a better outcome. The Health Assessment Questionnaire is based on 20 questions related to routine activities with a grading system ranging from 0 to 3 (0: no difficulty, 1: moderate difficulty, 2: severe difficulty, 3: total incapacity). A global score between 0 point to 60 points is established. a higher HAQ score means a worse outcome	once time, Baseline
Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22)	The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome. The sinonasal outcome test 22 is based on 22 questions with a grading from 0 to 5 ( 0: no probem, 1: very mild problem, 2: mild problem, 3: moderate problem, 4: severe problem, 5: very severe problem). A global score between 0 and 110 points is measured. A higher score means a worse outcome.	once time, Baseline
Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale.	The ETOC score ranges from 0 to 32 points ( as previously described ). A higher score means a better outcome. The Hospital anxiety and Depression (HAD) scale is based on 14 questions with a grading system ranging from 0 to 3. A global score between 0 and 42 is measured. A higher score means a worse outcome.	once time, Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: David Launay, MD,PhD, University Hospital, Lille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: 2018_84; 2019-A01083-54 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No