Back to resultsClinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study (PRECOSS)
Primary Purpose
Systemic Sclerosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
thoracic echography
Sponsored by
About this trial
This is an interventional diagnostic trial for Systemic Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Diagnosis of systemic scleroderma according to EULAR/ACR 2013 criteria
- Absence of diffuse interstitial lung disease proven by scanner on the day of inclusion
- Forced vital capacity ≥ 80% of the value predicted on the last respiratory function test performed.
- Carbon monoxide diffusion capacity corrected for hemoglobinemia ≥ 70% of the value predicted on the last respiratory function test performed.
- Patient capable of performing functional exploration during the year
- Affiliation to a social security system
- Patient who has given free and informed consent
Exclusion Criteria:
- Any other connectivity associated to systemic sleroderma
- Any chronic pathologies, co-morbidities, history judged by the investigator as being likely to lead to complications for the patient and/or which may impact the results of functional exploration during exercise.
- All known fibrotic and/or obstructive respiratory pathologies.
- Presence of echocardiographic signs of pulmonary arterial hypertension according to 2015 criteria
- Diagnosis of left heart disease
- Cumulative smoking > 10 packs.years
- Infectious pneumonia within 90 days prior to inclusion
- Acute respiratory illness requiring hospitalization within one year prior to inclusion
- Pregnant or breastfeeding woman
- Refusal to participate in the study
- Refusal to use the data
- Adults under legal protection (temporary protection measure, curatorship, guardianship)
Sites / Locations
- CHRU Tours
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Case group
Arm Description
The intervention of the research corresponds to the realization of a thoracic echography.
Outcomes
Primary Outcome Measures
Presence of interstitial syndrome on echography
Interstitial syndrome is defined by the total number of B lines is greather than or equal to 10 and/or the average thickness of the pleural line is greater than 3 mm on at least one test site and/or the irregularity score of the pleural line is greater than 16%
Secondary Outcome Measures
Ventilatory mechanics
Measured by spirometry
Ventilatory mechanics
Measured by plethysmography
Ventilatory mechanics
Measured by impulse oscillometry
Ventilatory mechanics
Measured by cardiopulmonary exercise testing
Pulmonary gas exchange
Measured by cardiopulmonary exercise testing
Pulmonary gas exchange
Measured by Diffusing capacity for carbon monoxide
Pulmonary gas exchange
Measured by 6-minute walk test
Exercise capacity
Measured by cardiopulmonary exercise testing
Circulatory response
Measured by cardiopulmonary exercise testing
Dyspnoea
Measured by cardiopulmonary exercise testing
Dyspnoea
Assessed by Dyspnea12
Dyspnoea
Assessed by Modified Medical Research Council (mMRC) Scale
Assessment of Quality of life
Assessed by Cochin 17-item Scleroderma Functional Scale
Assessment of Quality of life
Assessed by Saint George's Respiratory Questionnaire (SGRQ)
Cough
Evaluation by Leicester Cough Questionnaire - French translation
Full Information
NCT ID
NCT04725786
First Posted
January 13, 2021
Last Updated
June 17, 2022
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT04725786
Brief Title
Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study
Acronym
PRECOSS
Official Title
Pertinence Clinique de l'échographie Thoracique Pour le Diagnostic précoce de la Pneumopathie Interstitielle Diffuse de la sclérodermie systémique - Etude Pilote
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
June 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
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
Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis is essential to optimize this management. Current diagnostic techniques are based on high-resolution computed tomography on the thorax (HRCT) and pulmonary functional tests (PFT). However, these explorations have their limitations. Thus, there is a need for new techniques for a very early diagnosis of PID-SSc.
Thoracic ultrasound (TUS) is an innovative, easily accessible, non-irradiating, inexpensive and painless tool. It is an emerging technique for the diagnosis of PID and has already proven its sensitivity for the detection of interstitial damage, as defined by HRCT.
The main objective of the PRECOSS study is to describe the prevalence of an ultrasound interstitial syndrome in patients with SSc, free of PID-SSc (defined by the Goh criteria) detectable by HRCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case group
Arm Type
Experimental
Arm Description
The intervention of the research corresponds to the realization of a thoracic echography.
Intervention Type
Other
Intervention Name(s)
thoracic echography
Intervention Description
The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.
Primary Outcome Measure Information:
Title
Presence of interstitial syndrome on echography
Description
Interstitial syndrome is defined by the total number of B lines is greather than or equal to 10 and/or the average thickness of the pleural line is greater than 3 mm on at least one test site and/or the irregularity score of the pleural line is greater than 16%
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Ventilatory mechanics
Description
Measured by spirometry
Time Frame
At Baseline
Title
Ventilatory mechanics
Description
Measured by plethysmography
Time Frame
At Baseline
Title
Ventilatory mechanics
Description
Measured by impulse oscillometry
Time Frame
At Baseline
Title
Ventilatory mechanics
Description
Measured by cardiopulmonary exercise testing
Time Frame
At Baseline
Title
Pulmonary gas exchange
Description
Measured by cardiopulmonary exercise testing
Time Frame
At Baseline
Title
Pulmonary gas exchange
Description
Measured by Diffusing capacity for carbon monoxide
Time Frame
At baseline
Title
Pulmonary gas exchange
Description
Measured by 6-minute walk test
Time Frame
At baseline
Title
Exercise capacity
Description
Measured by cardiopulmonary exercise testing
Time Frame
At baseline
Title
Circulatory response
Description
Measured by cardiopulmonary exercise testing
Time Frame
At baseline
Title
Dyspnoea
Description
Measured by cardiopulmonary exercise testing
Time Frame
At baseline
Title
Dyspnoea
Description
Assessed by Dyspnea12
Time Frame
At baseline
Title
Dyspnoea
Description
Assessed by Modified Medical Research Council (mMRC) Scale
Time Frame
At baseline
Title
Assessment of Quality of life
Description
Assessed by Cochin 17-item Scleroderma Functional Scale
Time Frame
At baseline
Title
Assessment of Quality of life
Description
Assessed by Saint George's Respiratory Questionnaire (SGRQ)
Time Frame
At baseline
Title
Cough
Description
Evaluation by Leicester Cough Questionnaire - French translation
Time Frame
At baseline
Other Pre-specified Outcome Measures:
Title
Nailfold capillaroscopy
Description
Classification of Cutulo
Time Frame
At baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
Diagnosis of systemic scleroderma according to EULAR/ACR 2013 criteria
Absence of diffuse interstitial lung disease proven by scanner on the day of inclusion
Forced vital capacity ≥ 80% of the value predicted on the last respiratory function test performed.
Carbon monoxide diffusion capacity corrected for hemoglobinemia ≥ 70% of the value predicted on the last respiratory function test performed.
Patient capable of performing functional exploration during the year
Affiliation to a social security system
Patient who has given free and informed consent
Exclusion Criteria:
Any other connectivity associated to systemic sleroderma
Any chronic pathologies, co-morbidities, history judged by the investigator as being likely to lead to complications for the patient and/or which may impact the results of functional exploration during exercise.
All known fibrotic and/or obstructive respiratory pathologies.
Presence of echocardiographic signs of pulmonary arterial hypertension according to 2015 criteria
Diagnosis of left heart disease
Cumulative smoking > 10 packs.years
Infectious pneumonia within 90 days prior to inclusion
Acute respiratory illness requiring hospitalization within one year prior to inclusion
Pregnant or breastfeeding woman
Refusal to participate in the study
Refusal to use the data
Adults under legal protection (temporary protection measure, curatorship, guardianship)
Facility Information:
Facility Name
CHRU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Learn more about this trial
Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study
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