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NCT Number: NCT03528525

Registry Study on Respiratory Monogenic Diseases in Chinese Children

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.

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Key information

Conditions

Monogenic Diseases Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Children's hospital

Beijing, Beijing Municipality, 100045, China

Location status: Recruiting

Location contact

Kunling Shen, MD,PhD

CONTACT

[email protected]

861059616308

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Change from baseline in lung function on the spirometry

    Time frame: 1 year later

    forced expiratory volume at one second (FEV1) in Liter

Study contacts

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

Baoping Xu, MD,PhD

CONTACT

[email protected]

861059616308

Kunling Shen, MD,PhD

CONTACT

[email protected]

861059616308

Sponsors and collaborators

Lead sponsor

Kunling Shen

Other

Collaborators

  • Capital Institute of Pediatrics, China
  • Children's Hospital of Chongqing Medical University
  • Guangzhou Women and Children's Medical Center
  • Shengjing Hospital
  • The Children's Hospital of Zhejiang University School of Medicine
  • The first clinical college of Guangzhou medical university
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Yuying Children's Hospital of Wenzhou Medical University

Registry information

Official study title

Beijing Children's Hospital

Important dates

Study start
2017
Primary completion
2018
Study completion
2030
First posted
May 18, 2018
Registry last updated
May 18, 2018

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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