跳至主要内容
临床试验/NCT06346938
NCT06346938招募中不适用

The Clinical Significance of CT-based Biomarkers in the Classification and Prognosis of Bronchiectasis

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Frequency of acute exacerbations of bronchiectasis

研究概览

简要总结

As the third major chronic airway disease in China, bronchiectasis has a wide range of patients. However, the involved sites, morphological features and airway obstruction of bronchiectasis are varied, and clinical heterogeneity is high, making prognosis and severity difficult to evaluate. CT plays an important role in the diagnosis and classification of ramadasis. Based on this, we analyzed the CT findings of patients with bronchiectasis and followed up patients with bronchiectasis to understand their disease progression and prognosis, so as to further analyze the role of CT biomarkers in the type and prognosis of bronchiectasis diseases.

详细描述

Bronchiectasis is a common lung disease with a high incidence and low attention rate, and the imaging of bronchiectasis is characterized by diverse sites of involvement, morphological features and airway obstruction, as well as different clinical symptoms, severity and prognosis, and response to treatment. Therefore, how to establish a personalized prognostic evaluation system has also become a current research hotspot.

It has been demonstrated that chronic sputum aggregation or destruction of the airway wall leads to the appearance of emphysema, mucus plugs, and pulmonary solid changes in the lung parenchyma adjacent to the diseased bronchus. Emphysema and bronchiectasis share the same pathogenesis, such as chronic inflammation and alpha-1 trypsin deficiency, etc., and to some extent a vicious circle of mutual exacerbation. Thus subjects with coexisting emphysema tend to have a higher likelihood of infection compared to subjects with bronchiectasis without manifestations of emphysema. Emphysema is also recognized as an independent risk factor for 5-year mortality in patients with bronchiectasis. Meanwhile, high mucus secretion, another major manifestation in patients with bronchiectasis, which may be visualized on imaging as the formation of mucus plugs or dendritic signs, is a contributing factor to chronic obstruction in bronchiectasis and also appears to be the best predictor of mortality in patients with bronchiectasis. It can be concluded that different imaging manifestations in patients with bronchiectasis are closely related to clinical manifestations and prognosis. In this study, we attempted to establish a new assessment system of imaging severity by analyzing the imaging manifestations of patients with bronchiectasis and conducting a 3-year follow-up of the patients with bronchiectasis to further understand the clinical significance of imaging in the staging of bronchiectasis and the prognosis of the disease.

According to the inclusion and exclusion criteria, patients with confirmed diagnosis of bronchiectasis attending Union Hospital of Tongji Medical College, Huazhong University of Science and Technology between March 31, 2024 and March 31, 2027 were included in this study. At the time of enrollment, the researchers collected the subjects' demographic information, such as gender, age, height (m), weight (kg), clinical symptoms, such as cough, sputum, hemoptysis, dyspnea, blood test results, such as red blood cell count (10^12/L), hemoglobin (g/L), white blood cells (10^9/L), CRP (mg/L), sputum culture, and lung function test results, such as FVC (L), FVC (L), FVC (L), FVC (L), FVC (L), CRP (M), FVC (L), and sputum culture. , such as FVC (L), FEV1 (L), FEV1/FVC (%), and lung imaging (CT, etc.), such as type of bronchiectasis; degree of bronchiectasis, number of lung segments involved, grade of lung segments involved, and thickness of tubular wall; site of emphysema, its severity, number of segments involved, and its typology; site of mucus plugs, number of lung segments involved; lung abscesses; lung solids; and lung macroglossia.

Through the collection of the above data, the investigators will score the imaging and clinical manifestations of the patients, such as Bhalla score, Reiff score, BSI, FACED, emphysema grading, mucus plug score, etc. The subjects were also followed up every six months for three years after enrollment to obtain the number of acute exacerbations, number of hospitalizations, and patient survival per year in order to derive the relationship between imaging manifestations and prognosis and staging of bronchiectasis.

METHODS: In this study, blood, sputum, lung function and lung CT results were collected from the subjects during their normal visit to the clinic without any intervention and without any additional tests performed by the subjects. Where lung CT scores were scored according to Bhalla scoring criteria, Reiff scoring criteria respectively and scored by two medical imaging physicians.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and above;
  • Can cooperate with CT scan;
  • Bronchiectasis confirmed by high-resolution computed tomography of the lungs;
  • Can provide written informed consent

排除标准

  • Pulmonary surgery;
  • Patients with lung cancer, asthma and other respiratory diseases;
  • Tractive bronchiectasis caused by pulmonary fibrosis;
  • Patients with malignant tumors or serious dysfunction of the heart, brain, kidney and other important systems can not cooperate with the completion of this study;
  • Lack of important clinical information.

结局指标

主要结局

Frequency of acute exacerbations of bronchiectasis

时间窗: From the start of inclusion to one year later.

Acute exacerbations of bronchiectasis were defined according to the consensus published in the European Journal of Respiratory Sciences in 2017, and the frequency of acute exacerbations per year was obtained from participants through follow-up visits.

次要结局

  • Deterioration of lung function(From the start of inclusion to one year later.)
  • Mucus plug score(From the start of inclusion to one year later.)
  • Bhalla scores on CT of participants' lungs(From the start of inclusion to one year later.)
  • Frequency of hospitalisation(From the start of inclusion to one year later.)
  • Death(From the start of inclusion to one year later.)
  • Severity of dyspnoea(From the start of inclusion to one year later.)
  • Degree of emphysema(From the start of inclusion to one year later.)

研究者

发起方
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang xiaorong

Internal medicine physician

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究点 (1)

Loading locations...

相似试验