Registry Study on Cystic Fibrosis in Chinese Children

Registry Study on Cystic Fibrosis in Chinese Children-a Multicenter, Prospective Cohort Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02753374

Enrollment

100

Registered

2016-04-27

Start date

2016-05-31

Completion date

2030-07-31

Last updated

2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, Chinese, children

Brief summary

This study is a multicenter, prospective cohort study of patients diagnosed with cystic fibrosis, the clinical information of recruited patients, including clinical manifestations, lung function, chest imaging, quality of life and other indicators, will be followed for 10 years.

Detailed description

All new cases of cystic fibrosis which was confirmed or probably diagnosed at each center from the beginning of the study are made the investigation of the clinical manifestations, sweat test and CFTR mutations by the standard diagnostic process.Then all the patients' following clinical data will be followed for 10 years (once per six month): clinical manifestations, lung function, chest imaging (once per year), quality of life and other indicators.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* Age 0\ 18 years old * Any organ system symptoms consistent with CF, such as chronic sinopulmonary disease, gastrointestinal and nutritional abnormalities, obstructive azoospermia or having siblings with CF * CFTR dysfunction indicated by elevated sweat chloride levels ≥60 mmol/L twice, or one sweat chloride levels ≥40 mmol/L plus presence of two pathogenic CFTR mutations on different alleles * Probable CF patients with sweat chloride levels among 40\ 59 mmol/L plus with presence of 0-1 pathogenic CFTR mutation * Consent to provide the related clinical specimen to the certain hospital * The guardians of the patients fully understand the purpose of the study, volunteer their children to participate in this study and sign informed consent.

Exclusion criteria

* Subject will be excluded if she or he has one of the following: * It is unable to provide complete medical records or the current condition can not accept the diagnosis process. * She or he does not agree to participate in the test.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in lung function on the spirometry	ten years	forced expiratory volume at one second (FEV1) in Liter

Contacts

Primary ContactBaoping Xu, PhD

xubaopingbch@163.com861059616308

Outcome results