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Multi-Center Clinical Study on the Accuracy of the AI Mini-Program ‘EndNodule’ for Automated Preliminary Screening of Lung Nodule Risk

Multi-Center Clinical Study on the Accuracy of the AI Mini-Program ‘EndNodule’ for Automated Preliminary Screening of Lung Nodule Risk

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096366
Enrollment
Unknown
Registered
2025-01-22
Start date
2025-01-22
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary nodules

Interventions

Gold Standard:The gold standard in the study was the judgment of the thoracic surgeon and radiologist on the diagnosis CT report of the small nodule in the lung.
Index test:The judgment of the small pulmonary nodule CT diagnosis report by the small program ‘EndNodule’

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age: over 14 years old. 2) Gender: No limit. 3) Disease diagnostic criteria: For patients with imaging reports of small pulmonary nodules, the imaging reports should include clear descriptions and diagnostic opinions, and paper reports and electronic reports are not limited. 4) Relevant medical history: The patient had no history of thoracic surgery and no recent history of acute pulmonary infection; No history of malignancy. 5) Course of disease and treatment: Subjects should not have received any treatment that would significantly affect the evaluation of pulmonary nodules, such as surgery or antitumor therapy, or have solid tumors at other sites. 6) Informed consent: Previous imaging data from Zhongshan Hospital were selected in the retrospective study. The patient had signed the donation agreement and no informed consent was required. In prospective studies, subjects need to understand and agree to participate in the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Other treatment: Previous history of chest surgery 2) Complicated diseases: complicated with acute lung infection and malignant tumors in other parts 3) Cognitive impairment: severe cognitive impairment or mental illness, inability to understand the research process or cooperate with the research. 4) Image report quality: The image report is incomplete or of poor quality and cannot be effectively analyzed.

Design outcomes

Primary

MeasureTime frame
Sensitivity of the small program ‘EndNodule’ to the risk degree of pulmonary nodules;Specificity of the small program ‘EndNodule’ to the risk degree of pulmonary nodules;

Secondary

MeasureTime frame
False positive rate of the risk degree of pulmonary nodules judged by the small program ‘EndNodule’ ;False negative rate of risk assessment of pulmonary nodules by the small program ‘EndNodule’ ;

Countries

China

Contacts

Public ContactLu Chunlai

Zhongshan Hospital, Fudan University

lu.chunlai@zs-hospital.sh.cn+86 136 5191 7616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026