Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT03966066
Eligibility Criteria:
Inclusion Criteria:
All children participating in this clinical study must meet all of the following criteria.
1. age: 0-18 years old, male and female;
2. accord with diagnostic criteria of bronchiectasis;
3. Agreed to retain specimens related to disease research and to store them in a sample bank;
4. willing and able to cooperate with long term follow-up;
5. the guardian of the child has a good understanding of the purpose of the study, a basic understanding of the clinical research program, and voluntary participation of the child in the study and the signing of an informed consent form.
Diagnostic criteria of bronchiectasis: clinical manifestation + one or more clinical manifestations of high-resolution computed tomography (HRCT):
1. Clinical manifestations: recurrent cough, sputum, fixed wet rale in lung auscultation, clubbing finger (toe) and so on;
2. HRCT was more than one of the following: (1) In the lung segment, some distal end of a bronchial cavity diameter greater than or equal to the proximal end. the distal end of the lumen was greater than or equal to the proximal end of a segment of the bronchus. (2)The diameter of bronchus is larger than that of accompanied pulmonary artery. (3) the bronchus was seen within the area of 1.0cm under the chest wall. (4)Compared with the adjacent bronchi, the inner diameter of the bronchus was obviously larger than that of the adjacent lung segment, and the wall of the bronchus was thicker than that of the adjacent lung segment.
Exclusion Criteria:
All children with any of the following conditions must be excluded from this study:
1. children who are unable or unwilling to follow up regularly;
2. who are unable or unwilling to provide information on the history of the disease, The development of the disease and the response after treatment and other information in children.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03966066
Study Brief:
Protocol Section:
NCT03966066