A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules
- Conditions
- Solitary Lung NoduleMultiple Pulmonary Nodules
- Registration Number
- NCT06458673
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1184
- 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.
- ECOG 0～2
- Able to provide CT in DICOM format
- Informed consent obtained
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-year growth rate of subsolid pulmonary nodules 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.
- Secondary Outcome Measures
Name Time Method 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 Median length of time from patient enrollment to invasive diagnosis or therapeutic intervention such as surgical excision, biopsy, or other therapeutic procedures
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 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
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 the growth rate is calculated by comparing the initial and final diameters of the nodules during the follow-up period. Results are expressed as 1mm/year
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 the sensitivity and specificity is calculated by comparing the predicted results and the real results
Trial Locations
- Locations (1)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China