A Radiomic Model for Risk of Local Recurrence and DFS for T3 and T4 Non-small Cell Lung Cancer

May 7, 2024 updated by: Guangming Lu, Jinling Hospital, China

Development of a Tumor and Peritumor Radiomics-based Model to Predict the High-risk Surgical Margin and Prognosis of T3 and T4 Non-Small Cell Lung Cancer

The investigators retrospectively collected the participants with T3 and T4, N0-2, M0 NSCLC patients resected between January 2013 to December 2021 for training and internal validation. The Clinical data, preoperative laboratory results and images were collected. High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up, and the investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSO was used to select the features and tumor radiomics model, peritumor model and combined model were built using 5-fold cross-validation. And it was further tested on the independent cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), sensibility, specificity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

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

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jinling Hospital

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

N/A

Sampling Method

Probability Sample

Study Population

All T3 and T4 non-small cell lung cancers with surgery, and we retrospectively collected the preoperative enhanced chest CT and the recurrence location and time.

Description

Inclusion Criteria:

  • patients with T3 and T4 stage NSCLC；
  • available preoperative chest CTE within two weeks of surgery

Exclusion Criteria:

  • inadequate imaging quality resulted from breathing artifact;
  • without regularly follow-up information on recurrence location and time

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
Intervention / Treatment
high-risk surgical margin
High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up.
Other: tumor and peritumor radiomic feature
extracted the tumor and peritumor radiomic feature from the preoperative enhanced chest CT
Low-risk surgical margin
Low-risk margins were defined as R0 surgical margin meanwhile arising distant metastasis during follow-up.
Other: tumor and peritumor radiomic feature
extracted the tumor and peritumor radiomic feature from the preoperative enhanced chest CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free time and recurrence location
Time Frame: until the December 2023
the time from the surgery time to the recurrence time
until the December 2023

Collaborators and Investigators

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

Sponsor

Jinling Hospital, China

Investigators

  • Study Director: Guangming Lu, Department of Radiology, Jinling Hospital

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.

General Publications

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 (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

May 4, 2024

First Submitted That Met QC Criteria

May 4, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JinlingHospital_lungcancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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