Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma. (SCLERO-PID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03271333
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.

Condition or disease Intervention/treatment
Systemic Sclerosis Other: lung function tests

Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with systemic sclerosis Other: lung function tests
Patients hospitalized realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes)




Primary Outcome Measures :
  1. composite criteria: forced vital capacity and CO diffusing capacity [ Time Frame: At 24 months ]
    Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 24 months.


Secondary Outcome Measures :
  1. composite criteria: forced vital capacity and CO diffusing capacity [ Time Frame: At 12 months ]
    Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 12 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with systemic sclerosis and Diffuse Infiltrating Pneumonia
Criteria

Inclusion Criteria:

  • systemic sclerosis
  • Diffuse Infiltrating Pneumonia

Exclusion Criteria:

  • infection
  • other lung diseases
  • non French native

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271333


Contacts
Layout table for location contacts
Contact: David Launay, MD,PhD 3 20 44 42 95 ext +33 david.launay@chru-lille.fr

Locations
Layout table for location information
France
Hôpital Claude Huriez, CHU Recruiting
Lille, France
Contact: David Launay, MD,PHD       david.launay@chru-lille.fr   
AH-HP, Hôpital Saint Antoine Recruiting
Paris 12, France, 75571
Contact    0149282000      
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: David Launay, MD,PhD University Hospital, Lille
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03271333    
Other Study ID Numbers: 2015_49
2016-A00722-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Scleroderma, Systemic
Scleroderma, Diffuse
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases