Clinical trial NCT06405815: A Radiomic Model for Risk of Local Recurrence and DFS for T3 and T4 Non-small Cell Lung Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer, Nonsmall Cell
Keywords: non-small cell lung cancer
surgical margin
DFS
radiomics
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: disease free time and recurrence location
timeFrame: until the December 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Department of Radiology, Jinling Hospital
name: Guangming Lu
role: STUDY_DIRECTOR
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