跳至主要内容
临床试验/NCT05289245
NCT05289245招募中不适用

A National Registry on Clinical Manifestations, Genetics, Interventions, and Outcomes in Chinese Patients With Cystic Fibrosis (CF-CHINA)

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients.

研究概览

简要总结

Cystic fibrosis (CF) is a rare autosomal recessive disease involving multiple organs, especially the lungs and digestive organs. It is most commonly seen in Caucasians. Only a few Chinese CF patients have been described in literature, taking into account the large population of China. The main objectives of this study are to accurately evaluate the prevalence of CF, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in China.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Fulfilled WHO clinical diagnostic criteria for CF; Was in a stable phase with no respiratory infections for nearly 4 weeks; Subjects (or their guardians) signed informed consent.

排除标准

  • Patients with other bronchiectasis who did not meet the inclusion criteria; Those with severe cardiac or renal disease

结局指标

主要结局

Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients.

时间窗: 10 years

Spirometry will be evaluated at baseline and through study completion, an average of 3 years.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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