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

Multiple Pulmonary Nodules Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458673
• Other study ID #: CONAN
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: October 31, 2029

Study information

• Verified date: June 2024
• Source: Guangdong Provincial People's Hospital
• Contact: Xuening Yang, MD
• Phone: 0086-13922713300
• Email: yangxncn[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1184
• Est. completion date: October 31, 2029
• Est. primary completion date: October 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age= 18 years old, gender is not limited

• Subsolid pulmonary nodules confirmed by CT, with initial pulmonary nodules = 5 mm (including subsolid components) and = 30 mm

• ECOG 0~3

• No restriction on the type of surgery that can be performed

• 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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (17)

Lead Sponsor

Collaborator

Guangdong Provincial People's Hospital

Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Fifth Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Jinan University, Guangxi Medical University, Haikou People's Hospital, Hainan Cancer Hospital, Hunan Cancer Hospital, Peking University People's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Shanghai Zhongshan Hospital, Shantou Central Hospital, Shenzhen People's Hospital, Shenzhen Third People's Hospital, The Third People's Hospital of Chengdu, The Third Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Growth rate in different types of subsolid lung nodules	The growth rate of the nodules is calculated by comparing the initial and final diameters of the nodules during the follow-up period, in mm/year.	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	Efficacy of radiomics in diagnosis and predict growth in subsolid lung nodules	Radiomics used in monitoring the changes of radiological characteristics in nodules during follow-up period, as well as the rate of growth in the nodule diameter. Radiomics and standard diagnostic methods were compared to determine their accuracy and reliability.	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	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
Secondary	lung cancer 5-year disease-free survival	Disease free survival (DFS), defined as the time from enrollment to the first documented disease progression or death	From the time the patient is enrolled, and follow-up is initiated, up to 5 years of follow-up
Secondary	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