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NCT Number: NCT02753374

Registry Study on Cystic Fibrosis in Chinese Children

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from baseline in lung function on the spirometry

    Time frame: ten years

    forced expiratory volume at one second (FEV1) in Liter

Study contacts

Contact information is provided by the study sponsor or research team.

Baoping Xu, PhD

CONTACT

[email protected]

861059616308

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Collaborators

  • Capital Institute of Pediatrics, China
  • First Affiliated Hospital of Guangxi Medical University
  • Shanghai Children's Medical Center
  • Shengjing Hospital
  • Shenzhen Children's Hospital
  • The First Affiliated Hospital of Xiamen University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Apr 27, 2016
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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