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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05289245
Other study ID # XT 02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date October 1, 2032

Study information

Verified date March 2022
Source Peking Union Medical College Hospital
Contact Xinlun Tian, M.D.
Phone 86-10-69155039
Email tianxl@pumch.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 1, 2032
Est. primary completion date October 1, 2032
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 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. Exclusion Criteria: Patients with other bronchiectasis who did not meet the inclusion criteria; Those with severe cardiac or renal disease

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients. Spirometry will be evaluated at baseline and through study completion, an average of 3 years. 10 years
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