Registry of Chinese Patients with Lymphangioleiomyomatosis
A National Registry on Clinical Manifestations, Genetics, Interventions, and Outcomes in Chinese Patients With Lymphangioleiomyomatosis (LAM-CHINA)
Peking Union Medical College Hospital · NCT03193892
This study is creating a national registry to track the health and treatment of women with lymphangioleiomyomatosis in China to see how their lung function changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT03193892 on ClinicalTrials.gov |
What this trial studies
This study aims to create a national registry for pulmonary lymphangioleiomyomatosis (LAM) patients in China, focusing on evaluating the prevalence, disease status, diagnosis, treatment, quality of care, and health outcomes. It will last for four years and aims to enroll 800 female subjects diagnosed with LAM. The primary endpoint is to assess the annual change in pulmonary function through forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) measurements.
Who should consider this trial
Good fit: Ideal candidates for this study are women of any age with a confirmed or probable diagnosis of lymphangioleiomyomatosis.
Not a fit: Patients suspected of having LAM without supporting evidence or those without diffuse cystic lesions in the lung may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve understanding and management of LAM, leading to better patient outcomes.
How similar studies have performed: While there have been registries for other rare diseases, this specific approach for LAM in China is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gender: female. 2. Age: no limitation. 3. Diagnosis meets one of the following criteria, (1) definite or probable diagnosis of LAM based on ATS/JRS and ERS criteria. (2) Investigators recommend including of the patient. Exclusion Criteria: 1. Suspected LAM patients without other supporting evidence for LAM diagnosis. 2. No diffuse cystic lesions in the lung. 3. Patients with bilateral cystic lung lesions but the LAM diagnosis cannot be established. 4. Without signed informed consent. 5. Difficult to follow up.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Kai-Feng Xu, M.D.
- Email: xukf@pumch.cn
- Phone: 86-10-69155039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Function, registry, China, lymphangioleiomyomatosis