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

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ClinicalTrials.gov Identifier: NCT04178616
Recruitment Status : Terminated (Following the COVID-related health crisis, nasofibroscopic sampling could no longer be carried out)
First Posted : November 26, 2019
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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

Condition or disease Intervention/treatment Phase
Olfactory Disorders Scleroderma Diagnostic Test: olfactory testing with specific odorants (localisation and identification) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study is single-group epidemiologic study, without any control group.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma
Actual Study Start Date : December 31, 2019
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
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 Name: nasofibroscopy to identify sinonasal mucosa diseases




Primary Outcome Measures :
  1. Percentage of patient with hyposmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to 27 points [ Time Frame: once time, Baseline ]
    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 :
  1. Percentage of patient with anosmia defined by a ETOC (European Test of Olfactory Capabilities) score strictly inferior to10 points [ Time Frame: once time, Baseline ]
    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.

  2. Percentage of patients with an unilateral Lund Kennedy score of more than 3 points. [ Time Frame: once time, Baseline ]
    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.

  3. Measurement of systemic sclerosis disease activity with Medsger Score [ Time Frame: once time, Baseline ]
    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.

  4. Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Medsger Score [ Time Frame: once time, Baseline ]

    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.


  5. Correlation between global olfactory score measured with ETOC score and skin involvement severity measured with Rodnan score. [ Time Frame: once time, Baseline ]

    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


  6. Correlation between global olfactory score measured with ETOC score and systemic sclerosis disease activity measured with Health Assessment Questionnaire (HAQ) score [ Time Frame: once time, Baseline ]

    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


  7. Correlation between global olfactory score measured with ETOC score and the rhinologic quality of life score measured with the sinonasal outcome test 22) [ Time Frame: once time, Baseline ]

    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.


  8. Correlation between global olfactory score measured with ETOC and Hospital anxiety and Depression (HAD) scale. [ Time Frame: once time, Baseline ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178616


Locations
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France
Hop Claude Huriez Chu Lille
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: David Launay, MD,PhD University Hospital, Lille
Publications of Results:
Other Publications:
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04178616    
Other Study ID Numbers: 2018_84
2019-A01083-54 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases