NCT07304856 Role of Extracellular Vesicles as Biomarkers of Pulmonary Involvement in Patients With Lymphangioleiomyomatosis and Tuberous Sclerosis Complex
| NCT ID | NCT07304856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Milan |
| Condition | Lymphangioleiomyomatosis (LAM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2026-01-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-04-16 with a primary completion date of 2026-01-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07304856 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Lymphangioleiomyomatosis (LAM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07304856 currently recruiting?
Yes, NCT07304856 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Milan to inquire about joining.
Where is the NCT07304856 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07304856 clinical trial?
NCT07304856 is sponsored by University of Milan. The trial plans to enroll 80 participants.