Prediction of Growth Trend of Pulmonary Nodules Based on Multi-temporal and Multimodal Medical Data and Its Impact on Pulmonary Nodule Management Strategies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,184
- 试验地点
- 1
- 主要终点
- 5-year growth rate of subsolid pulmonary nodules
研究概览
简要总结
Some studies have shown that the model for judging and predicting the growth of sub-solid pulmonary nodules through big data and deep learning can detect nodule growth earlier. Since most of the training data come from large foreign samples, most of the validated data are CT data from a single center or a few centers, and their generalization ability needs to be further verified. In order to better study subsolid pulmonary nodules in the lungs in China, we plan to conduct a prospective, multicenter, non-interventional observational cohort study.
详细描述
Through the follow-up of pulmonary nodules, artificial intelligence based on CT was used to study the natural evolution process of subsolid pulmonary nodules, as well as the development law and prognosis of pulmonary subsolid nodules under treatment or no treatment according to clinical guidelines.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥ 18 years old, gender is not limited
- •Confirmed subsolid pulmonary nodule by CT, initial pulmonary nodule ≥ 5 mm (including subsolid components) and ≤ 30 mm, do not shrink or disappear after 3 months Follow-up.
- •Able to provide CT in DICOM format
- •Informed consent obtained
排除标准
- •Long-term use of immunosuppressants and hormone drugs
- •History of previous malignancy (if there is no recurrence or carcinoma in situ for more than 5 years after receiving curative therapy, it can be enrolled)
- •Inability to cooperate with regular follow-up
- •Poor general condition, with the life expectancy less than 6 months
结局指标
主要结局
5-year growth rate of subsolid pulmonary nodules
时间窗: Regular follow-up was carried out according to clinical guidelines and local hospital guidelines, with an interval of 3-6 months and a duration of 5 years
The 5-year growth rate of the nodules is calculated by comparing the initial and final diameters of the nodules during the follow-up period.Results are expressed as percentages.
次要结局
- Median time from enrollment to invasive diagnosis/intervention in patients with subsolid pulmonary nodules(The time from patient enrollment and initiation of follow-up until invasive diagnosis/intervention)
- Lung cancer-specific 5-year survival rate(From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up)
- explore the growth rate and pattern of radiographic changes of different types of pulmonary nodules(From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up)
- Sensitivity and specificity of radiomics in predicting the growth of subsolid pulmonary nodules(From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up)
研究者
Xue-Ning Yang
Vice-Chief of Guangdong Lung Cancer Institute
Guangdong Provincial People's Hospital