A National Registry on Chinese Patients With Cystic Fibrosis
A National Registry on Clinical Manifestations, Genetics, Interventions, and Outcomes in Chinese Patients With Cystic Fibrosis (CF-CHINA)
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2032
March 21, 2022
March 1, 2022
10.5 years
March 13, 2022
March 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Study Population is from across the country of China.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2022
First Posted
March 21, 2022
Study Start
April 1, 2022
Primary Completion (Estimated)
October 1, 2032
Study Completion (Estimated)
October 1, 2032
Last Updated
March 21, 2022
Record last verified: 2022-03