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Clinical Trials/NCT05289245
NCT05289245
Recruiting
Not Applicable

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

Peking Union Medical College Hospital1 site in 1 country200 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Function
Sponsor
Peking Union Medical College Hospital
Enrollment
200
Locations
1
Primary Endpoint
Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients.
Status
Recruiting
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
October 1, 2032
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 10 years

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

Study Sites (1)

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