Multiple Pulmonary Nodules, Solitary Lung Nodule
Conditions
Keywords
Lung Nodule, Prospective, Observational Study
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.
Interventions
None listed
Sponsors
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
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXuening Yang, MD
Outcome results
None listed