Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry Study on Respiratory Monogenic Diseases in Chinese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528525
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Capital Institute of Pediatrics, China
Shengjing Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The Children's Hospital of Zhejiang University School of Medicine
Children's Hospital of Chongqing Medical University
The first clinical college of Guangzhou medical university
Guangzhou Women and Children's Medical Center
Yuying Children's Hospital of Wenzhou 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 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.

Condition or disease
Monogenic Diseases

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Beijing Children's Hospital
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2018
Estimated Study Completion Date : December 30, 2030

Group/Cohort
Monogenic diseases cases



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month 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 respiratory monogenic diseases at the certain hospitals (sponsor and collaborators)
Criteria

Inclusion Criteria:

  1. Age: 0-18 years, male and female.
  2. Any organ system symptoms consistent with the diagnostic points of respiratory monogenic diseases.
  3. Agree to retain specimens related to disease research and agree to store the specimens in the sample bank.
  4. willing and able to cooperate with long-term follow-up.
  5. 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:

  1. It is unable to provide complete medical records or the current condition can not accept the diagnosis process
  2. She or he cannot agree to participate in the study.

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): NCT03528525


Contacts
Layout table for location contacts
Contact: Kunling Shen, MD,PhD 861059616308 kunlingshen1717@163.com
Contact: Baoping Xu, MD,PhD 861059616308 xubaopingbch@163.com

Locations
Layout table for location information
China, Beijing
Beijing Children's hospital Recruiting
Beijing, Beijing, China, 100045
Contact: Kunling Shen, MD,PhD    861059616308    kunlingshen1717@163.com   
Sponsors and Collaborators
Kunling Shen
Capital Institute of Pediatrics, China
Shengjing Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The Children's Hospital of Zhejiang University School of Medicine
Children's Hospital of Chongqing Medical University
The first clinical college of Guangzhou medical university
Guangzhou Women and Children's Medical Center
Yuying Children's Hospital of Wenzhou Medical University
Additional Information:

Layout table for additonal information
Responsible Party: Kunling Shen, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT03528525    
Other Study ID Numbers: BCHlung 010
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kunling Shen, Beijing Children's Hospital:
Diseases
Children
Respiratory
Monogenic diseases
China