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Constructing a Predictive Model for Differentiating Between Benign and Malignant Solid Pulmonary Nodules Based on Clinical and Imaging Features.

Combined With Clinical and Imaging Features, the Prediction Model of Benign and Malignant Solid Pulmonary Nodules Was Constructed

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06685458
Enrollment
320
Registered
2024-11-12
Start date
2024-11-15
Completion date
2025-02-20
Last updated
2024-11-12

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

Conditions

Lung Cancer, Pulmonary Nodules, Solid Pulmonary Nodules

Keywords

Lung Cancer Screening, Nodule Malignancy Prediction, Preoperative Imaging Analysis

Brief summary

Study Objective: To comprehensively analyze the preoperative clinical and imaging characteristics of solid pulmonary nodules, investigate the risk factors associated with malignant solid pulmonary nodules, and provide a reference for preoperative treatment decisions. Significance of the Study: According to the 2020 Global Cancer Report, lung cancer remains the leading cause of cancer-related deaths worldwide. While the majority of patients with stage I lung cancer achieve long-term survival, survival rates for advanced-stage patients are extremely low. Early screening, diagnosis, and treatment of lung cancer are crucial. With the widespread implementation of early lung cancer screening, a growing number of pulmonary nodules are being detected, among which solid pulmonary nodules constitute a significant proportion. Unlike ground-glass nodules, accurately distinguishing between benign and malignant solid nodules is critical for determining appropriate treatment strategies. For benign solid nodules, follow-up observation is the preferred approach, whereas early surgical intervention is essential for malignant solid nodules. Although previous studies have explored the correlation between clinical and imaging characteristics, they have not conducted systematic analyses, and most have been based on small sample sizes. Therefore, this study aims to conduct a comprehensive analysis of preoperative clinical and imaging characteristics, build a predictive model to differentiate between benign and malignant solid pulmonary nodules, and provide a reliable reference for selecting treatment strategies.

Detailed description

Our study evaluate patients with SPN from the Third Affiliated Hospital of Kunming Medical University. The patient selection followed specific inclusion and exclusion criteria. Inclusion criteria included: (1) All subjects provided CT imaging obtained from the Third Affiliated Hospital of Kunming Medical University within 2-week period prior to surgery; (2) Complete clinicopathological data of solid nodules were obtained; (3) Surgical intervention for one or more SPN; (4) No prior anti-tumor treatments like radiotherapy or chemotherapy; (5) Age 18 years or older. Exclusion criteria involved: (1) Patients with incomplete imaging data or medical records; (2) Lung infections that could affect image analysis; (3) Significant respiratory movement artifacts in images impairing imaging analysis; (4) Inconsistent locations of SPN in postoperative pathology reports and preoperative CT images.

Interventions

OTHERPreoperative Clinical and Imaging Feature Evaluation for Predictive Modeling

This study involves preoperative evaluation of clinical and imaging features for constructing a predictive model to differentiate benign and malignant solid pulmonary nodules. Surgical resection is performed to obtain pathological confirmation as the reference standard.

Sponsors

The Third Affiliated Hospital of Kunming Medical College.
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* (1) All subjects provided CT imaging obtained from the Third Affiliated Hospital of Kunming Medical University within 2-week period prior to surgery; (2) Complete clinicopathological data of solid nodules were obtained; (3) Surgical intervention for one or more SPN; (4) No prior anti-tumor treatments like radiotherapy or chemotherapy; (5) Age 18 years or older.

Exclusion criteria

* (1) Patients with incomplete imaging data or medical records; (2) Lung infections that could affect image analysis; (3) Significant respiratory movement artifacts in images impairing imaging analysis; (4) Inconsistent locations of SPN in postoperative pathology reports and preoperative CT images.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance of predictive modelWithin 2 years after surgical resection and pathological confirmationThe primary outcome is the area under the receiver operating characteristic curve (AUC) of the predictive model in distinguishing benign from malignant solid pulmonary nodules, based on preoperative clinical and imaging features.

Contacts

Primary Contactyantao yang
2443804244@qq.com18288509115
Backup Contactlianhua ye
Lhye1204@aliyun.com13769123627

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026