A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules

Prediction of Growth Trend of Pulmonary Nodules Based on Multi-temporal and Multimodal Medical Data and Its Impact on Pulmonary Nodule Management Strategies

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Pulmonary Nodules; Solitary Lung Nodule

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.

• Study Type: Observational
• Enrollment (Estimated): 1184

Contacts and Locations

• Study Contact: Name: Xuening Yang, MD; Phone Number: 0086-13922713300; Email: yangxncn@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
      • Contact: Xuening Yang, MD; Phone Number: 0086-13922713300; Email: yangxncn@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with subsolid pulmonary nodules of 5 to 30 mm in size found on CT

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year growth rate of subsolid pulmonary nodules	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.	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

Outcome Measure	Measure Description	Time Frame
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-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
explore the growth rate and pattern of radiographic changes of different types of pulmonary nodules	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	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	the sensitivity and specificity is calculated by comparing the predicted results and the real results	From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Guangxi Medical University; Peking University People's Hospital; Shanghai Zhongshan Hospital; Hunan Cancer Hospital; The Third Xiangya Hospital of Central South University; Shenzhen People's Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University; First Affiliated Hospital of Jinan University; Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Second Affiliated Hospital of Guangzhou Medical University; Shantou Central Hospital; Shenzhen Third People's Hospital; The Third People's Hospital of Chengdu; Hainan Cancer Hospital; Haikou People's Hospital
• Investigators: Principal Investigator: Xuening Yang, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 9, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Observational Study; Prospective; Lung Nodule
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: CONAN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No