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Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma.

Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03271333
Acronym
SCLERO-PID
Enrollment
56
Registered
2017-09-05
Start date
2018-04-10
Completion date
2025-12-11
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

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.

Interventions

Patients hospitalized realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes)

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* systemic sclerosis * Diffuse Infiltrating Pneumonia

Exclusion criteria

* infection * other lung diseases * non French native

Design outcomes

Primary

MeasureTime frameDescription
composite criteria: forced vital capacity and CO diffusing capacityAt 24 monthsDegradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 24 months.

Secondary

MeasureTime frameDescription
composite criteria: forced vital capacity and CO diffusing capacityAt 12 monthsDegradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 12 months.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026