A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules
NCT Number: NCT06458673
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Solitary Lung Nodule|Multiple Pulmonary Nodules
Sponsor: Guangdong Provincial People's Hospital
Collaborators: Third Affiliated Hospital, Sun Yat-Sen University|Fifth Affiliated Hospital, Sun Yat-Sen University|Peking University People's Hospital|Guangxi Medical University|Shanghai Zhongshan Hospital|The Third Xiangya Hospital of Central South University|Affiliated Cancer Hospital & Institute of Guangzhou Medical University|The Third People's Hospital of Chengdu|Shantou Central Hospital|Hainan Cancer Hospital|Shenzhen People's Hospital|Hunan Cancer Hospital|Shenzhen Third People's Hospital|First Affiliated Hospital of Jinan University|Haikou People's Hospital|Second Affiliated Hospital of Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1184
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2029-10-31
Locations: Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China

Summary:
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.

Primary Outcome Measures: Growth rate in different types of subsolid lung nodules, The growth rate of the nodules is calculated by comparing the initial and final diameters of the nodules during the follow-up period, in mm/year., 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
Secondary Outcome Measures: Efficacy of radiomics in diagnosis and predict growth in subsolid lung nodules, Radiomics used in monitoring the changes of radiological characteristics in nodules during follow-up period, as well as the rate of growth in the nodule diameter. Radiomics and standard diagnostic methods were compared to determine their accuracy and reliability., 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|Median time from enrollment to invasive diagnosis/intervention in patients with subsolid pulmonary nodules, Median length of time from patient enrollment to invasive diagnosis or therapeutic intervention such as surgical excision, biopsy, or other therapeutic procedures, The time from patient enrollment and initiation of follow-up until invasive diagnosis/intervention|lung cancer 5-year disease-free survival, Disease free survival (DFS), defined as the time from enrollment to the first documented disease progression or death, From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up|Lung cancer-specific 5-year survival rate, Lung cancer-specific 5-year survival rate is defined as a proportion of patients diagnosed with lung cancer who survive within 5 years of diagnosis, From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
Other Outcome Measures: Explore the radiographic features of subsolid pulmonary nodules in long-term follow-up, The study will assess the correlation between these changes and the patient's clinical outcomes, as well as possible biomarkers, From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up|explore the biomarkers associated with the development of subsolid pulmonary nodules, We will analyze blood and tissue samples from patients to identify molecular markers that may be associated with the progression of nodules, From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up