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NCT05289245 Clinical Trial

A National Registry on Chinese Patients With Cystic Fibrosis

Pulmonary Function Clinical Trial

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

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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