Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study (PRECOSS)

• ClinicalTrials.gov Identifier: NCT04725786
• Recruitment Status: Recruiting
• First Posted: January 27, 2021
• Last Update Posted: May 21, 2021
• Sponsor: University Hospital, Tours
• Information provided by (Responsible Party): University Hospital, Tours

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.

Condition or disease	Intervention/treatment	Phase
Systemic Sclerosis	Other: thoracic echography	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pertinence Clinique de l'échographie Thoracique Pour le Diagnostic précoce de la Pneumopathie Interstitielle Diffuse de la sclérodermie systémique - Etude Pilote
• Actual Study Start Date: March 17, 2021
• Estimated Primary Completion Date: September 17, 2022
• Estimated Study Completion Date: September 17, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Case group; The intervention of the research corresponds to the realization of a thoracic echography.	Other: thoracic echography; The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.

Outcome Measures

Primary Outcome Measures :

1. Presence of interstitial syndrome on echography [ 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%

Secondary Outcome Measures :

1. Ventilatory mechanics [ Time Frame: At Baseline ]
   Measured by spirometry
2. Ventilatory mechanics [ Time Frame: At Baseline ]
   Measured by plethysmography
3. Ventilatory mechanics [ Time Frame: At Baseline ]
   Measured by impulse oscillometry
4. Ventilatory mechanics [ Time Frame: At Baseline ]
   Measured by cardiopulmonary exercise testing
5. Pulmonary gas exchange [ Time Frame: At Baseline ]
   Measured by cardiopulmonary exercise testing
6. Pulmonary gas exchange [ Time Frame: At baseline ]
   Measured by Diffusing capacity for carbon monoxide
7. Pulmonary gas exchange [ Time Frame: At baseline ]
   Measured by 6-minute walk test
8. Exercise capacity [ Time Frame: At baseline ]
   Measured by cardiopulmonary exercise testing
9. Circulatory response [ Time Frame: At baseline ]
   Measured by cardiopulmonary exercise testing
10. Dyspnoea [ Time Frame: At baseline ]
    Measured by cardiopulmonary exercise testing
11. Dyspnoea [ Time Frame: At baseline ]
    Assessed by Dyspnea12
12. Dyspnoea [ Time Frame: At baseline ]
    Assessed by Modified Medical Research Council (mMRC) Scale
13. Assessment of Quality of life [ Time Frame: At baseline ]
    Assessed by Cochin 17-item Scleroderma Functional Scale
14. Assessment of Quality of life [ Time Frame: At baseline ]
    Assessed by Saint George's Respiratory Questionnaire (SGRQ)
15. Cough [ Time Frame: At baseline ]
    Evaluation by Leicester Cough Questionnaire - French translation

Other Outcome Measures:

1. Nailfold capillaroscopy [ Time Frame: At baseline ]
   Classification of Cutulo

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

France

CHRU Tours; Recruiting

Tours, France, 37044

Contact: Elisabeth DIOT, Dr 247479819 ext +33 elisabeth.diot@univ-tours.fr

Sponsors and Collaborators

University Hospital, Tours

More Information

• Responsible Party: University Hospital, Tours
• ClinicalTrials.gov Identifier: NCT04725786
• Other Study ID Numbers: DR20098; 2020-A03249-30 ( Registry Identifier: ID-RCB )
• First Posted: January 27, 2021
• Last Update Posted: May 21, 2021
• Last Verified: May 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Scleroderma, Systemic; Scleroderma, Diffuse; Connective Tissue Diseases; Skin Diseases