Registry Study on Respiratory Monogenic Diseases in Chinese Children
Beijing Children's Hospital
1 other identifier
observational
200
1 country
1
Brief Summary
This study is a multicenter, prospective cohort study of patients diagnosed with respiratory monogenic diseases, the clinical information of recruited patients, including clinical manifestations, lung function, chest imaging, quality of life and other indicators, will be followed for 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 6, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2030
ExpectedMay 18, 2018
May 1, 2018
1 year
May 6, 2018
May 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in lung function on the spirometry
forced expiratory volume at one second (FEV1) in Liter
1 year later
Study Arms (1)
Monogenic diseases cases
Eligibility Criteria
Children who was confirmed diagnosis as respiratory monogenic diseases at the certain hospitals (sponsor and collaborators)
You may qualify if:
- Age: 0-18 years, male and female.
- Any organ system symptoms consistent with the diagnostic points of respiratory monogenic diseases.
- Agree to retain specimens related to disease research and agree to store the specimens in the sample bank.
- willing and able to cooperate with long-term follow-up.
- The guardian of the child has a full understanding of the purpose of the study, a basic understanding of the clinical research program, and voluntarily allows the child to participate in the study and sign an informed consent form.
You may not qualify if:
- It is unable to provide complete medical records or the current condition can not accept the diagnosis process
- She or he cannot agree to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kunling Shenlead
- Capital Institute of Pediatrics, Chinacollaborator
- Shengjing Hospitalcollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- The Children's Hospital of Zhejiang University School of Medicinecollaborator
- Children's Hospital of Chongqing Medical Universitycollaborator
- The first clinical college of Guangzhou medical universitycollaborator
- Guangzhou Women and Children's Medical Centercollaborator
- Yuying Children's Hospital of Wenzhou Medical Universitycollaborator
Study Sites (1)
Beijing Children's hospital
Beijing, Beijing Municipality, 100045, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Beijing Children's Hospital
Study Record Dates
First Submitted
May 6, 2018
First Posted
May 18, 2018
Study Start
January 1, 2017
Primary Completion
January 1, 2018
Study Completion (Estimated)
December 30, 2030
Last Updated
May 18, 2018
Record last verified: 2018-05