A National Registry on Chinese Patients With Lymphangioleiomyomatosis
ConditionPulmonary Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorPeking Union Medical College Hospital
About this trial
Pulmonary lymphangioleiomyomatosis (LAM), a disease characterized by diffuse cystic changes in the lung, is a rare disorder that affects almost exclusively women. The main objectives of this study are to accurately evaluate the prevalence of LAM, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in China.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gender: female.
Age: no limitation.
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.
Disqualifiers
Suspected LAM patients without other supporting evidence for LAM diagnosis.
No diffuse cystic lesions in the lung.
Patients with bilateral cystic lung lesions but the LAM diagnosis cannot be established.
Without signed informed consent.
Trial population
Study Population is from across the country of China.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients.
Spirometry will be evaluated at baseline and through study completion, an average of 3 years.
Time frame
10 yearsSecondary outcomes
1
Change of diffusing capacity of the lung.
Pulmonary function tests will be evaluated at baseline and through study completion, an average of 3 years.
Time frame
10 years2
Annual incidence of major health outcomes: hemoptysis, pneumothorax, chylothorax, and spontaneous hemorrhage of kidney angiomyolipoma (AML).
The number of occurrences will be recorded through study completion, an average of 3 years.
Time frame
10 years3
Other health outcomes: pregnancy, malignant tumors except LAM, lung transplantation, and death.
The number of occurrences will be recorded through study completion, an average of 3 years.
Time frame
10 year4
The incidence of adverse drug reactions of long-time treatment with rapamycin.
Common Terminology Criteria for Adverse Events (CTCAE) will be used to evaluate adverse drug reactions through study completion, an average of 3 years.
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Guangzhou Institute of Respiratory Disease
Collaborator
Central South University
Collaborator
Anhui Provincial Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Wuxi People's Hospital
Collaborator
Beijing Shijitan Hospital, Capital Medical University
Collaborator
West China Hospital
Collaborator
Fujian Provincial Hospital
Collaborator
Wuhan TongJi Hospital
Collaborator
Source ClinicalTrials.gov