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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Pulmonary Function

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