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Study of the Prevalence of Acid Sphingomyelinase Deficiency/Niemann Pick AB and B Disease in Patients With Diffuse Interstitial Lung Disease

Study acronym: Niemann-PID
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Wladimir MAUHIN, Dr

Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of May 2025 to Jun 5, 2025
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints expanded, about 98 words
    • Site details revised
    • Study description expanded, about 4 words
  2. Start date: Apr 2025 to May 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to optimise and facilitate screening for Acid SphingoMyelinase Deficiency (ASMD) disease, by evaluating acid sphingomyelinase activity and, where appropriate, LysoSM levels in a cohort of 200 participants with diffuse interstitial lund disease (ILD) at risk of developing ASMD disease. ILD is common in the general population, so in order to limit the number of differential diagnoses, the population to be studied will be restricted to participants aged between 15 years and 3 months and 60 years, with ILD plus ground-glass opacities on chest CT scan certified by a pulmonologist/radiologist or internist, AND splenomegaly or splenectomy, and/or thrombocytopenia, and/or low HDL cholesterol, and/or parental consanguinity which increase the sensitivity of ASMD screening. In this clinical trail, two procedures are added, participants will be asked for : * a blood sample to measure the acid sphingomyelinase enzyme activity and LysoSM, if required. * a follow-up visit at 6 months
Trial Details
NCT Number NCT06869499
Lead Sponsor Wladimir MAUHIN, Dr
Collaborators: Bichat Hospital, Hospital Avicenne, Rennes University Hospital, Bicetre Hospital, University Hospital, Marseille, Tenon Hospital, Paris, Centre Hospitalier Universitaire Dijon, University Hospital, Lille, Hospices Civils de Lyon
Conditions
(from sponsor)		 Splenomegaly, Splenectomy, Thrombopenia, Interstitial Lung Disease (ILD), Hypocholesterolemia
Related terms Lung Diseases, Interstitial, Niemann-Pick Diseases, Splenomegaly, Thrombocytopenia
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov