- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06645743
Retrospective Analysis of Clinical and CT Features to Predict Spread Through Air Space in Stage IA Lung Adenocarcinoma
Clinical and Imaging Features Were Used to Predict the Occurrence of Spread Through Air Space in Stage IA Lung Adenocarcinoma
Study Overview
Status
Detailed Description
Referring from Global Cancer Report 2020, lung cancer remains the leading cause of tumor death, with adenocarcinoma as the primary histological subtype. In 2021, the World Health Organization (WHO) proposed a new classification standard for lung cancer, dividing adenocarcinomas into in-situ adenocarcinomas, microinvasive adenocarcinomas, and invasive adenocarcinomas based on their invasive development.
Due to the widespread popularization of early screening for lung cancer, a growing number of IA lung adenocarcinomas cases manifesting as lung nodules have been detected, and surgical resection remains the most critical treatment options for such individuals. With the emergence of relevant research results, sublobectomy has become a preferred method for early stage IA lung adenocarcinoma. However, some individuals with lung adenocarcinoma in stage IA undergoing sublobectomy still have recurrence and metastasis, in which spread through air spaces (STAS) plays vital role.
STAS was formally proposed by WHO in 2015 as a new invasion mode of invasive lung adenocarcinoma. STAS is characterized by pathological micropapillary clusters, solid nests, or isolated cells located beyond the tumor margin, counting one or more, infiltrating the air spaces within the surrounding lung parenchyma and detached from the primary tumor, rather than forming distinct tumor islands. A number of studies have pointed out that STAS is associated with poor prognosis of patients, many researchers continue to favor lobectomy when treating patients with stage IA lung adenocarcinoma exhibiting positive STAS.
Due to the limitations of intraoperative frozen section in predicting STAS, preoperative application of clinical and imaging features in predicting STAS shows great advantages. Former research has suggested that clinical and imaging characteristics can predict occurrence of STAS, despite the difference of results from different studies. Onozato et al. believe that smokers are more likely to develop STAS, which is consistent with the study by Shiono et al. However, Uruga et albelieved that the occurrence of STAS was unrelated to smoking. Warth et al. believed that male lung adenocarcinoma patients were more prone to STAS, while Kadota stated the occurrence of STAS was unrelated to patient gender.
However, the sample size included in these previous studies is small, and the parameters included by various scholars are different, and there is still a lack of large sample studies systematically analyzing clinical and imaging characteristics to predict the spread through air space of stage IA lung adenocarcinoma. Therefore, we plan to carry out this study. Based on a large sample size, the clinical and imaging characteristics of patients with stage IA lung adenocarcinoma were comprehensively analyzed to predict the spread through air space, so as to provide a reference for the selection of surgical methods
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yantao Yang
- Phone Number: +86 18288509115
- Email: 2443804244@qq.com
Study Contact Backup
- Name: Huilian Hu
- Phone Number: +86 13769123627
- Email: 1922957250@qq.com
Study Locations
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Yunnan
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Kunming, Yunnan, China, 650000
- The Third Affiliated Hospital of Kunming Medical University
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Contact:
- Lianhua Ye
- Phone Number: +86 13508801068
- Email: Lhye1204@aliyun.com
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Contact:
- Yaowu Duan
- Phone Number: +86 19086653462
- Email: 34763399775@qq.com
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Principal Investigator:
- Yantao Yang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Preoperative CT images reported that the maximum diameter of pulmonary nodules was less than 3 cm
All subjects provided CT imaging obtained from Yunnan Cancer Hospital within a 2-week period prior to surgery
Postoperative pathological diagnosis of invasive lung adenocarcinoma
Remote metastasis was excluded by preoperative imaging (CT, PET-CT, ultrasound, etc.)
Age ≥ 18 years
Exclusion Criteria:
Incomplete collection of medical records, imaging data, or hematology data
Preoperative complications of other malignant tumors
Unclear correspondence between postoperative pathological report and preoperative CT nodule location
Images do not meet analysis conditions due to pulmonary infection or large respiratory motion artifacts
Postoperative pathology revealed two or more nodules classified as infiltrating adenocarcinoma
Prior lung surgery or preoperative neoadjuvant therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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spread through air space positive group
The patients in this group were stage IA lung adenocarcinoma patients who met the inclusion and exclusion criteria, and the postoperative pathological results indicated the presence of spread through air space
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spread through air space negative group
The patients in this group were stage IA lung adenocarcinoma patients who met the inclusion and exclusion criteria, and the postoperative pathological results showed no spread through air space
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accuracy of Predicting Spread Through Air Spaces (STAS) in Stage IA Lung Adenocarcinoma Using Clinical and Imaging Features
Time Frame: Preoperative clinical and imaging data collected within 2 weeks prior to surgery, retrospectively analyzed from patients who underwent surgery within the past 3 years
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This outcome measure assesses the accuracy of using preoperative clinical and CT imaging features to predict the presence of spread through air spaces (STAS) in patients with stage IA lung adenocarcinoma.Measure: Area Under the ROC Curve (AUC), sensitivity, and specificity for the prediction model.
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Preoperative clinical and imaging data collected within 2 weeks prior to surgery, retrospectively analyzed from patients who underwent surgery within the past 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prognostic Impact of STAS on Recurrence-Free Survival
Time Frame: From the date of surgery to the time of disease recurrence or last follow-up, up to 5 years.
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This outcome measure investigates whether the presence of STAS in stage IA lung adenocarcinoma is associated with recurrence-free survival (RFS).
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From the date of surgery to the time of disease recurrence or last follow-up, up to 5 years.
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Collaborators and Investigators
Investigators
- Study Director: Lianhua Ye, The Third Affiliated Hospital of Kunming Medical University
Publications and helpful links
Helpful Links
- Provides global information and statistics on lung cancer
- A free search engine providing access to a vast collection of biomedical and life sciences literature, including MEDLINE-indexed articles, covering topics such as medicine, pharmacology, and healthcare research.
- The Third Affiliated Hospital of Kunming Medical University provides comprehensive cancer care, including surgery, radiotherapy, chemotherapy, and immunotherapy, along with advanced diagnostic and imaging services.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYLX2023-137
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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