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Completed

NCT Number: NCT04725786

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

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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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Tours

Tours, 37044, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

thoracic echography

Other

The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.

Primary outcomes

  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 outcomes

  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 outcomes

  1. Nailfold capillaroscopy

    Time frame: At baseline

    Classification of Cutulo

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Pertinence Clinique de l'échographie Thoracique Pour le Diagnostic précoce de la Pneumopathie Interstitielle Diffuse de la sclérodermie systémique - Etude Pilote

Acronym: PRECOSS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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