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Recruiting NCT03528525

Registry Study on Respiratory Monogenic Diseases in Chinese Children

— Observational Monogenic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Monogenic Diseases. Basic parameters: 1 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Beijing Children's Hospital

Overview

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.

Detailed description

All new cases of respiratory monogenic diseases was confirmed or diagnosed at each center from the beginning of the study are made the investigation of the clinical manifestations and specific tests by the standard diagnostic process.Then all the patients' following clinical data will be followed for 5 years: clinical manifestations, lung function, chest imaging (once per year), gene test, quality of life and other indicators.

Interventions

  • Other
    observation

Primary outcome measures

  • Change from baseline in lung function on the spirometry [Time frame: 1 year later]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Beijing Children's hospital — Beijing

Identifiers

NCT: NCT03528525 · BCHlung 010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗