Clinical trial NCT06458673: A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Solitary Lung Nodule
Multiple Pulmonary Nodules
Keywords: Lung Nodule
Prospective
Observational Study
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Third Affiliated Hospital, Sun Yat-Sen University
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Peking University People's Hospital
name: Guangxi Medical University
name: Shanghai Zhongshan Hospital
name: The Third Xiangya Hospital of Central South University
name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: The Third People's Hospital of Chengdu
name: Shantou Central Hospital
name: Hainan Cancer Hospital
name: Shenzhen People's Hospital
name: Hunan Cancer Hospital
name: Shenzhen Third People's Hospital
name: First Affiliated Hospital of Jinan University
name: Haikou People's Hospital
name: Second Affiliated Hospital of Guangzhou Medical University
First posted: 2024-06-13
Enrollment: 1184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subsolid pulmonary nodules of 5 to 30 mm in size found on CT

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.

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

Primary outcomes:
measure: 5-year growth rate of subsolid pulmonary nodules
timeFrame: 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 outcomes:
measure: Median time from enrollment to invasive diagnosis/intervention in patients with subsolid pulmonary nodules
timeFrame: The time from patient enrollment and initiation of follow-up until invasive diagnosis/intervention
measure: Lung cancer-specific 5-year survival rate
timeFrame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
measure: explore the growth rate and pattern of radiographic changes of different types of pulmonary nodules
timeFrame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
measure: Sensitivity and specificity of radiomics in predicting the growth of subsolid pulmonary nodules
timeFrame: From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Xuening Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: