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

NCT ID: NCT06645743

Last Updated: 2024-10-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-25

Study Completion Date

2025-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tomography, X-Ray Computed Spread Through Air Space Clinical Features Stage IA Adenocarcinoma of Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Third Affiliated Hospital of Kunming Medical College.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yantao Yang

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lianhua Ye

Role: STUDY_DIRECTOR

The Third Affiliated Hospital of Kunming Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Third Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yantao Yang

Role: CONTACT

+86 18288509115

Huilian Hu

Role: CONTACT

+86 13769123627

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lianhua Ye

Role: primary

+86 13508801068

Yaowu Duan

Role: backup

+86 19086653462

Related Links

Access external resources that provide additional context or updates about the study.

https://www.who.int

Provides global information and statistics on lung cancer

https://pubmed.ncbi.nlm.nih.gov

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.

https://www.ynszlyy.com

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.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KYLX2023-137

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.