NCT06645743

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2025

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 11, 2024

Last Update Submit

October 15, 2024

Conditions

Keywords

clinical featureRadiologic characteristicLung adenocarcinomaspread through air space

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Predicting Spread Through Air Spaces (STAS) in Stage IA Lung Adenocarcinoma Using Clinical and Imaging Features

    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 Outcomes (1)

  • Prognostic Impact of STAS on Recurrence-Free Survival

    From the date of surgery to the time of disease recurrence or last follow-up, up to 5 years.

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

Related Links

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Study Officials

  • Lianhua Ye

    The Third Affiliated Hospital of Kunming Medical University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 17, 2024

Study Start

October 25, 2024

Primary Completion

February 21, 2025

Study Completion

February 21, 2025

Last Updated

October 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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

Locations