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Registry Study on Cystic Fibrosis in Chinese Children

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ClinicalTrials.gov Identifier: NCT02753374
Recruitment Status : Not yet recruiting
First Posted : April 27, 2016
Last Update Posted : April 28, 2016
Sponsor:
Collaborators:
Shengjing Hospital
Capital Institute of Pediatrics, China
Shanghai Children's Medical Center
Shenzhen Children's Hospital
The First Affiliated Hospital of Xiamen University
First Affiliated Hospital of Guangxi Medical University
Information provided by (Responsible Party):
Kunling Shen, Beijing Children's Hospital

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.

Condition or disease
Cystic Fibrosis

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry Study on Cystic Fibrosis in Chinese Children-a Multicenter, Prospective Cohort Study
Study Start Date : May 2016
Estimated Primary Completion Date : May 2030
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis




Primary Outcome Measures :
  1. Change from baseline in lung function on the spirometry [ Time Frame: ten years ]
    forced expiratory volume at one second (FEV1) in Liter



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children who was confirmed diagnosis as cystic fibrosis at the certain hospitals (sponsor and collaborators)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753374


Contacts
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Contact: Baoping Xu, PhD 861059616308 xubaopingbch@163.com

Sponsors and Collaborators
Beijing Children's Hospital
Shengjing Hospital
Capital Institute of Pediatrics, China
Shanghai Children's Medical Center
Shenzhen Children's Hospital
The First Affiliated Hospital of Xiamen University
First Affiliated Hospital of Guangxi Medical University
Investigators
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Principal Investigator: Kunling Shen, MD, PhD Beijing Children's Hospital of Capital Medical University, China, China National Clinical Research Center for Respiratory Diseases
Principal Investigator: Baoping Xu, MD, PhD Beijing Children's Hospital of Capital Medical University, China, China National Clinical Research Center for Respiratory Diseases

Publications:
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Responsible Party: Kunling Shen, Chief of China National Clinical Research Center for Respiratory Diseases, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT02753374     History of Changes
Other Study ID Numbers: BCHlung004
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Keywords provided by Kunling Shen, Beijing Children's Hospital:
cystic fibrosis, Chinese, children
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases