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Biomarkers Of Lung InVolvement In ASMD

Biomarkers Of Lung InVolvement In ASMD - BOLIVIA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54323
Enrollment
68
Registered
2021-03-16
Start date
2022-12-05
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

acid sphingomyelinase deficiency Niemann-Pick disease

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients - biochemical and genetically confirmed diagnosis of ASMD - written informed consent prior to the study-related procedure. - >= 12 years of age Healthy subjects: - written informed consent prior to the study-related procedure - >= 18 years of age

Exclusion criteria

Exclusion criteria: Patients: - Inability to adhere to the study protocol Healthy subjects: - Medical history of pulmonary disease - Inability to adhere to the study protocol

Design outcomes

Primary

MeasureTime frame
Inflammatory markers, fibrotic markers and markers of sphingolipid accumulation will be measured in exhaled breath. Breath profiles will be measured with eNose, volatile compounds will be measured with GC-MS and non-volatile compounds will be measured in exhaled breath condensates using UPLC-MS/MS.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)