CHRU Tours
Tours, 37044, France
NCT Number: NCT04725786
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.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Tours, 37044, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.
Time frame: At baseline
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
Measured by spirometry
Time frame: At Baseline
Measured by plethysmography
Time frame: At Baseline
Measured by impulse oscillometry
Time frame: At Baseline
Measured by cardiopulmonary exercise testing
Time frame: At Baseline
Measured by cardiopulmonary exercise testing
Time frame: At baseline
Measured by Diffusing capacity for carbon monoxide
Time frame: At baseline
Measured by 6-minute walk test
Time frame: At baseline
Measured by cardiopulmonary exercise testing
Time frame: At baseline
Measured by cardiopulmonary exercise testing
Time frame: At baseline
Measured by cardiopulmonary exercise testing
Time frame: At baseline
Assessed by Dyspnea12
Time frame: At baseline
Assessed by Modified Medical Research Council (mMRC) Scale
Time frame: At baseline
Assessed by Cochin 17-item Scleroderma Functional Scale
Time frame: At baseline
Assessed by Saint George's Respiratory Questionnaire (SGRQ)
Time frame: At baseline
Evaluation by Leicester Cough Questionnaire - French translation
Time frame: At baseline
Classification of Cutulo
University Hospital, Tours
Other
Pertinence Clinique de l'échographie Thoracique Pour le Diagnostic précoce de la Pneumopathie Interstitielle Diffuse de la sclérodermie systémique - Etude Pilote
Acronym: PRECOSS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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