A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Solitary Lung Nodule, Multiple Pulmonary Nodules. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prediction of Growth Trend of Pulmonary Nodules Based on Multi-temporal and Multimodal Medical Data and Its Impact on Pulmonary Nodule Management Strategies
Overview
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.
Primary outcome measures
- 5-year growth rate of subsolid pulmonary nodules [Time frame: 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 (4)
- Median time from enrollment to invasive diagnosis/intervention in patients with subsolid pulmonary nodules [Time frame: The time from patient enrollment and initiation of follow-up until invasive diagnosis/intervention]
- Lung cancer-specific 5-year survival rate [Time frame: 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 [Time frame: 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 [Time frame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT06458673 · CONAN