A National Registry on Chinese Patients With Lymphangioleiomyomatosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03193892|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||A National Registry on Clinical Manifestations, Genetics, Interventions, and Outcomes in Chinese Patients With Lymphangioleiomyomatosis (LAM-CHINA)|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
- Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients. [ Time Frame: 3 years ]Spirometry will be evaluated at baseline and through study completion, an average of 3 years.
- Change of diffusing capacity of the lung. [ Time Frame: 3 years ]Pulmonary function tests will be evaluated at baseline and through study completion, an average of 3 years.
- Annual incidence of major health outcomes: hemoptysis, pneumothorax, chylothorax, and spontaneous hemorrhage of kidney angiomyolipoma (AML). [ Time Frame: 3 years ]The number of occurrences will be recorded through study completion, an average of 3 years.
- Other health outcomes: pregnancy, malignant tumors except LAM, lung transplantation, and death. [ Time Frame: 3 year ]The number of occurrences will be recorded through study completion, an average of 3 years.
- The incidence of adverse drug reactions of long-time treatment with rapamycin. [ Time Frame: 3 years ]Common Terminology Criteria for Adverse Events (CTCAE) will be used to evaluate adverse drug reactions through study completion, an average of 3 years.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193892
|Contact: Kai-Feng Xu, M.D.||email@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Kai-Feng Xu, M.D. 86-10-69155039 firstname.lastname@example.org|
|Contact: XinLun Tian, M.D. 86-10-69155039 email@example.com|
|Sub-Investigator: Xinlun Tian, M.D.|
|Principal Investigator: Kai-Feng Xu, M.D.|