Sporadic LymphangioleiomyomatosisNCT06405997
The Genotype and Phenotype of Lymphangioleiomyomatosis
An observational study of Sporadic Lymphangioleiomyomatosis and TSC-associated Lymphangioleiomyomatosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to differentiate between sporadic Lymphangioleiomyomatosis and Tuberous Sclerosis Complex-associated Lymphangioleiomyomatosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sporadic Lymphangioleiomyomatosis, TSC-associated Lymphangioleiomyomatosis
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 May 2024to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Chest CT showed cystic lung disease, suspected Lymphangioleiomyomatosis in National Taiwan University Hospital
Who may be able to join
- age ≥ 18 y/o
- Patient with Chest CT showed cystic lung disease, suspected Lymphangioleiomyomatosis
Who cannot join
- age < 18 y/o
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yao-Wen Kuo, MD, 0972-651-821, kyw@ntu.edu.tw
About this study
This study aims to differentiate between sporadic Lymphangioleiomyomatosis and Tuberous Sclerosis Complex-associated Lymphangioleiomyomatosis.
- Keywords
- Lymphangioleiomyomatosis
- Medical subject headings
- Lymphangioleiomyomatosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The genotype and phenotype of lymphangioleiomyomatosis
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start10 May 2024 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sporadic LymphangioleiomyomatosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Wen Kuo, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405997
- Sponsor's protocol ID
- 202401140RINE
- Status last verified
- Apr 2024
- First submitted
- 2 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genotype and Phenotype of Lymphangioleiomyomatosis
- ClinicalTrials.gov ID
- NCT06405997
- Acronym / sponsor ID
- 202401140RINE
- Keywords
- Lymphangioleiomyomatosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to differentiate between sporadic Lymphangioleiomyomatosis and Tuberous Sclerosis Complex-associated Lymphangioleiomyomatosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Chest CT showed cystic lung disease, suspected Lymphangioleiomyomatosis in National Taiwan University Hospital
Key inclusion criteria (2 listed)
- age ≥ 18 y/o
- Patient with Chest CT showed cystic lung disease, suspected Lymphangioleiomyomatosis
Key exclusion criteria (1 listed)
- age < 18 y/o
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The genotype and phenotype of lymphangioleiomyomatosis
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Related trials for Sporadic Lymphangioleiomyomatosis
RecruitingObservational study
Role of Extracellular Vesicles as Biomarkers of Pulmonary Involvement in Patients With Lymphangioleiomyomatosis and Tuberous Sclerosis Complex
Lymphangioleiomyomatosis (LAM), Extracellular Vesicles; Generation and Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yao-Wen Kuo principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sporadic Lymphangioleiomyomatosis and TSC-associated Lymphangioleiomyomatosis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao-Wen Kuo (0972-651-821, kyw@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The genotype and phenotype of lymphangioleiomyomatosis (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.