Cystic FibrosisNCT02753374
Registry Study on Cystic Fibrosis in Chinese Children
An observational study of Cystic Fibrosis, run by Beijing Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who was confirmed diagnosis as cystic fibrosis at the certain hospitals (sponsor and collaborators)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Registry Study on Cystic Fibrosis in Chinese Children-a Multicenter, Prospective Cohort Study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, Chinese, children
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in lung function on the spirometry
forced expiratory volume at one second (FEV1) in Liter
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Kunling Shen, Beijing Children's Hospital
- Investigators
- Kunling Shen, MD, PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, China, China National Clinical Research Center for Respiratory DiseasesBaoping Xu, MD, PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, China, China National Clinical Research Center for Respiratory Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753374
- Sponsor's protocol ID
- BCHlung004
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kerem B, Rommens JM, Buchanan JA, Markiewicz D, Cox TK, Chakravarti A, Buchwald M, Tsui LC. Identification of the cystic fibrosis gene: genetic analysis. Science. 1989 Sep 8;245(4922):1073-80. doi: 10.1126/science.2570460.
PubMed 2570460Comeau AM, Parad RB, Dorkin HL, Dovey M, Gerstle R, Haver K, Lapey A, O'Sullivan BP, Waltz DA, Zwerdling RG, Eaton RB. Population-based newborn screening for genetic disorders when multiple mutation DNA testing is incorporated: a cystic fibrosis newborn screening model demonstrating increased sensitivity but more carrier detections. Pediatrics. 2004 Jun;113(6):1573-81. doi: 10.1542/peds.113.6.1573.
PubMed 15173476Nazer HM. Early diagnosis of cystic fibrosis in Jordanian children. J Trop Pediatr. 1992 Jun;38(3):113-5. doi: 10.1093/tropej/38.3.113.
PubMed 1507302Al-Mahroos F. Cystic fibrosis in bahrain incidence, phenotype, and outcome. J Trop Pediatr. 1998 Feb;44(1):35-9. doi: 10.1093/tropej/44.1.35.
PubMed 9538604Yamashiro Y, Shimizu T, Oguchi S, Shioya T, Nagata S, Ohtsuka Y. The estimated incidence of cystic fibrosis in Japan. J Pediatr Gastroenterol Nutr. 1997 May;24(5):544-7. doi: 10.1097/00005176-199705000-00010.
PubMed 9161949Brennan ML, Schrijver I. Cystic Fibrosis: A Review of Associated Phenotypes, Use of Molecular Diagnostic Approaches, Genetic Characteristics, Progress, and Dilemmas. J Mol Diagn. 2016 Jan;18(1):3-14. doi: 10.1016/j.jmoldx.2015.06.010. Epub 2015 Nov 26.
PubMed 26631874