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

NCT06458673 | Not Yet Recruiting DMC

• 1 other identifier: CONAN
• Study Type: observational
• Target: 1,184
• Locations: 1 country
• Sites: 1

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.

Conditions

Solitary Lung Nodule; Multiple Pulmonary Nodules

Keywords

Lung Nodule; Prospective; Observational Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Xuening Yang, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuening Yang, MD

CONTACT

0086-13922713300; yangxncn@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chief of Guangdong Lung Cancer Institute

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CN (1)