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

NCT ID: NCT06458673

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2030-11-30

Brief Summary

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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

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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.

Conditions

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Solitary Lung Nodule Multiple Pulmonary Nodules

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Guangxi Medical University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The Third People's Hospital of Chengdu

OTHER

Sponsor Role collaborator

Shantou Central Hospital

OTHER

Sponsor Role collaborator

Hainan Cancer Hospital

OTHER

Sponsor Role collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role collaborator

Haikou People's Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xue-Ning Yang

Vice-Chief of Guangdong Lung Cancer Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuening Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Xuening Yang, MD

Role: CONTACT

0086-13922713300

Facility Contacts

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Xuening Yang, MD

Role: primary

0086-13922713300

Other Identifiers

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CONAN

Identifier Type: -

Identifier Source: org_study_id