Retrospective Analysis of Clinical and CT Features to Predict Spread Through Air Space in Stage IA Lung Adenocarcinoma

October 15, 2024 updated by: Yantao Yang, The Third Affiliated Hospital of Kunming Medical College.

Clinical and Imaging Features Were Used to Predict the Occurrence of Spread Through Air Space in Stage IA Lung Adenocarcinoma

The purpose of this study is to provide a basis for the selection of surgical methods for patients with stage IA lung adenocarcinoma. Air cavity dissemination is a poor prognostic factor for patients with stage IA lung adenocarcinoma. We retrospectively collected clinical and imaging data of stage IA lung adenocarcinoma patients. Independent risk factors associated with spread through air space in stage IA lung adenocarcinoma patients were analyzed, so as to predict the occurrence of spread through air space and provide basis for the selection of surgical methods

Study Overview

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

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Yunnan
      • Kunming, Yunnan, China, 650000
        • The Third Affiliated Hospital of Kunming Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yantao Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from patients diagnosed with Stage IA lung adenocarcinoma after surgery who have undergone preoperative evaluation of clinical and CT imaging at the Third Affiliated Hospital of Kunming Medical University within the past five years

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Preoperative clinical and imaging data collected within 2 weeks prior to surgery, retrospectively analyzed from patients who underwent surgery within the past 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This outcome measure investigates whether the presence of STAS in stage IA lung adenocarcinoma is associated with recurrence-free survival (RFS).
From the date of surgery to the time of disease recurrence or last follow-up, up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lianhua Ye, The Third Affiliated Hospital of Kunming Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 25, 2024

Primary Completion (Estimated)

February 21, 2025

Study Completion (Estimated)

February 21, 2025

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated and/or analyzed during the current study are not publicly available due sharing data is not included in our research institution review board but are available from the corresponding author on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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