ClinicalTrials.gov record NCT07304856

Role of Extracellular Vesicles as Biomarkers of Pulmonary Involvement in Patients With Lymphangioleiomyomatosis and Tuberous Sclerosis Complex

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Prospective Observational Study of the Role of Extracellular Vesicles (EVs) as Biomarkers of Pulmonary Involvement in Patients With Sporadic Lymphangioleiomyomatosis (S-LAM) and Tuberous Sclerosis Complex-Associated LAM (TSC-LAM)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age18 years old to 80 years old

SexFemale

LocationItaly

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study will enroll female participants with confirmed sporadic LAM, TSC-associated LAM, TSC without lung involvement, and healthy controls. At a routine visit the study collects blood and performs lung-function tests; plasma extracellular vesicles (EVs) will be isolated and analyzed for number, size, and molecular content. Results will be compared between the groups and correlated with clinical and lung-function data.

What it is studying. The study tests whether characteristics of plasma extracellular vesicles (EVs)—their concentration, size, and molecular cargo—differ between women with S-LAM, TSC-LAM, TSC without pulmonary involvement, and healthy controls, and whether EV features relate to disease severity, pulmonary complications, lung function, or use of mTOR-inhibitor therapy.

What the researchers hope to learn. Compare EV number and morphology across S-LAM, TSC-LAM, TSC without lung involvement, and healthy controls. Determine the molecular contents of EVs (miRNA, proteins, lipids, metabolites) using omics analyses. Assess whether mTOR-inhibitor therapy (sirolimus or everolimus) is associated with EV count or morphology. Explore associations between EV characteristics and overall disease severity, pulmonary complications, and measured lung function.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Lymphangioleiomyomatosis (LAM) is a rare lung disease, linked to Tuberous Sclerosis Complex (TSC) or occurring sporadically, and involves abnormal mTORC1 activation. LAM cells are neoplastic, and recent focus has turned to extracellular vesicles (EVs), which mediate tumor progression and may serve as biomarkers. This study, conducted at the Pulmonology Unit of ASST Santi Paolo e Carlo and the Pharmacology Laboratory of the University of Milan, will analyze the characteristics of serum EVs in patients with LAM and TSC. During scheduled outpatient visits, clinical and functional data and blood samples will be collected. Plasma will be separated, and EVs will be isolated via centrifugation. EVs will be analyzed for size, concentration, and molecular content (proteins, lipids, nucleic acids). The results obtained will be collected and correlated with the clinical and functional data.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test: Pulmonary Function Test
Analysis of Extracellular Vesicles

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Female participants aged ≥18 years Confirmed diagnosis of tuberous sclerosis complex (TSC) and/or lymphangioleiomyomatosis (definite diagnosis of TSC-LAM or S-LAM) Follow-up at the Pulmonology Unit of ASST Santi Paolo e Carlo, Milan Ability to provide written informed consent

Exclusion criteria

Diagnosis of "probable" or "possible" LAM Refusal to provide written informed consent

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will attend scheduled outpatient visits where the team will collect clinical and functional data, perform lung function tests (spirometry, body plethysmography, DLCO) and a six-minute walk test, and take blood samples. Blood will be processed to make plasma and isolate extracellular vesicles for laboratory analysis (size, concentration, and molecular content). Procedures are non‑invasive aside from blood draws and exercise testing; participants must give written consent. The study does not list more invasive procedures.

How the study is structured. A prospective, cross-sectional observational study. Participants attend a scheduled outpatient visit to give a blood sample and undergo lung-function testing (spirometry, body plethysmography, DLCO, and a six-minute walk). Plasma will be processed to isolate EVs for particle counting, size measurement, and molecular ('omics') analyses. No experimental treatment is given or assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on lymphangioleiomyomatosis

This trial is also listed on this site under tuberous sclerosis complex.

Clinical trials10 trials listed for lymphangioleiomyomatosisEvery trial the registry lists for lymphangioleiomyomatosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in lymphangioleiomyomatosis researchLatest monthly update: September 2026. Includes: Pleural fluid drainage. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Apr 16, 2025
Primary completion: Jan 16, 2026 (estimated)
Study completion: Aug 20, 2026 (estimated)
Target enrollment: 80 participants (estimated)
Last updated on registry: Dec 26, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: University of Milan
Principal investigator: Michele Mondoni, MD, associated professor of respiratory medicine
University of Milan

Participating sites (1)

Pulmonology Unit ASST Santi Paolo e Carlo, Ospedale San PaoloRecruiting
Milan, Milano, 20142 · Italy
- Silvia Terraneo, MD, PhD · +390281843025 · silvia.terraneo@asst-santipaolocarlo.it

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
Follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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