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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04725786
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Tours
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Sclerosis
Arms & Interventions

Arms

Experimental: Case group

The intervention of the research corresponds to the realization of a thoracic echography.

Interventions

Other: - thoracic echography

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHRU Tours, Tours, France

Status

Recruiting

Address

CHRU Tours

Tours, , 37044

Site Contact

Elisabeth DIOT, Dr

elisabeth.diot@univ-tours.fr

247479819 #+33