Back to resultsAssessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma (SCLEROLF)
Primary Purpose
Olfactory Disorders, Scleroderma
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
olfactory testing with specific odorants (localisation and identification)
Sponsored by
About this trial
This is an interventional diagnostic trial for Olfactory Disorders
Eligibility Criteria
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…)
Sites / Locations
- Hop Claude Huriez Chu Lille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
systemic sclerosis patients population
Arm Description
All the patients with systemic sclerosis disease followed in day-care in a tertiary hospital are eligible to be enrolled in the study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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
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
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.
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.
Full Information
NCT ID
NCT04178616
First Posted
September 30, 2019
Last Updated
November 17, 2020
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT04178616
Brief Title
Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
Acronym
SCLEROLF
Official Title
Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Following the COVID-related health crisis, nasofibroscopic sampling could no longer be carried out
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfactory Disorders, Scleroderma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is single-group epidemiologic study, without any control group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
systemic sclerosis patients population
Arm Type
Other
Arm Description
All the patients with systemic sclerosis disease followed in day-care in a tertiary hospital are eligible to be enrolled in the study.
Intervention Type
Diagnostic Test
Intervention Name(s)
olfactory testing with specific odorants (localisation and identification)
Other Intervention Name(s)
nasofibroscopy to identify sinonasal mucosa diseases
Intervention Description
Olfactory testing : ETOC (European Test of Olfactory capabilities)
Primary Outcome Measure Information:
Title
Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points
Description
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.
Time Frame
once time, Baseline
Secondary Outcome Measure Information:
Title
Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points
Description
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.
Time Frame
once time, Baseline
Title
Percentage of patients with an unilateral Lund Kennedy score of more than 3 points.
Description
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.
Time Frame
once time, Baseline
Title
Measurement of systemic sclerosis disease activity with Medsger Score
Description
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.
Time Frame
once time, Baseline
Title
Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score
Description
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.
Time Frame
once time, Baseline
Title
Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score.
Description
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
Time Frame
once time, Baseline
Title
Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score
Description
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
Time Frame
once time, Baseline
Title
Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22)
Description
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.
Time Frame
once time, Baseline
Title
Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale.
Description
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.
Time Frame
once time, Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Launay, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25424576
Citation
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.
Results Reference
background
PubMed Identifier
29444467
Citation
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.
Results Reference
result
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Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
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