Role of Extracellular Vesicles as Biomarkers of Pulmonary Involvement in Patients With Lymphangioleiomyomatosis and Tuberous Sclerosis Complex
NCT ID: NCT07304856
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2025-04-16
2026-08-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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S-LAM
Patients with sporadic LAM
Pulmonary Function Test
Spirometry, Plethysmography, Diffusing capacity of the lungs for carbon monoxide (DLCO), and Six-minute walk test (6MWT).
Analysis of Extracellular Vesicles
From the venous blood sample, plasma will be separated, and extracellular vesicles (EVs) will be isolated through serial centrifugation steps. The EVs will be analyzed to assess their concentration (particles/mL) and size (nanometers, nm). Additionally, omics analyses will be performed to study the molecular content of the EVs, including nucleic acids, proteins, and lipids.
TSC-LAM
Patients with TSC-associated LAM
Pulmonary Function Test
Spirometry, Plethysmography, Diffusing capacity of the lungs for carbon monoxide (DLCO), and Six-minute walk test (6MWT).
Analysis of Extracellular Vesicles
From the venous blood sample, plasma will be separated, and extracellular vesicles (EVs) will be isolated through serial centrifugation steps. The EVs will be analyzed to assess their concentration (particles/mL) and size (nanometers, nm). Additionally, omics analyses will be performed to study the molecular content of the EVs, including nucleic acids, proteins, and lipids.
TSC
Patients with TSC and no pulmonary involvement
Pulmonary Function Test
Spirometry, Plethysmography, Diffusing capacity of the lungs for carbon monoxide (DLCO), and Six-minute walk test (6MWT).
Analysis of Extracellular Vesicles
From the venous blood sample, plasma will be separated, and extracellular vesicles (EVs) will be isolated through serial centrifugation steps. The EVs will be analyzed to assess their concentration (particles/mL) and size (nanometers, nm). Additionally, omics analyses will be performed to study the molecular content of the EVs, including nucleic acids, proteins, and lipids.
Control
Healthy subjects
Pulmonary Function Test
Spirometry, Plethysmography, Diffusing capacity of the lungs for carbon monoxide (DLCO), and Six-minute walk test (6MWT).
Analysis of Extracellular Vesicles
From the venous blood sample, plasma will be separated, and extracellular vesicles (EVs) will be isolated through serial centrifugation steps. The EVs will be analyzed to assess their concentration (particles/mL) and size (nanometers, nm). Additionally, omics analyses will be performed to study the molecular content of the EVs, including nucleic acids, proteins, and lipids.
Interventions
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Pulmonary Function Test
Spirometry, Plethysmography, Diffusing capacity of the lungs for carbon monoxide (DLCO), and Six-minute walk test (6MWT).
Analysis of Extracellular Vesicles
From the venous blood sample, plasma will be separated, and extracellular vesicles (EVs) will be isolated through serial centrifugation steps. The EVs will be analyzed to assess their concentration (particles/mL) and size (nanometers, nm). Additionally, omics analyses will be performed to study the molecular content of the EVs, including nucleic acids, proteins, and lipids.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
FEMALE
Yes
Sponsors
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University of Milan
OTHER
Responsible Party
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Michele Mondoni
MD, associated professor of respiratory medicine
Locations
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Pulmonology Unit ASST Santi Paolo e Carlo, Ospedale San Paolo
Milan, Milano, Italy
Countries
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Facility Contacts
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Silvia Terraneo, MD, PhD
Role: primary
Other Identifiers
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LAM_EVs
Identifier Type: -
Identifier Source: org_study_id