Radiomics and Radiogenomics of Non-small Cell Lung Cancer

Not Applicable

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Diagnostic Test: Radiomic signature

• Registration Number: NCT06331975
• Lead Sponsor: European Institute of Oncology

Brief Summary

In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up

Detailed Description

Non-small cell lung cancers (NSCLC) are the first cause of cancer-related deaths.

Recent guidelines suggest the key role of a wide molecular profile because knowledge of the tumor genotype can enable patients with NSCLC to be treated with targeted therapies.

In this study, a first group of patients with lung adenocarcinoma (study group), tested for the presence of genetic alterations in EGFR, ALK, and KRAS, and with available Computer Tomography (CT) scans, will be evaluated to create a radiomic signature and assess its association with mutational status and prognosis.

Then, a second group of patients (validation group) will be enrolled to validate the radiomic signature and the status of the genetic alterations and their association with prognosis. Radiomic signature and liquid biopsies will be evaluated in patients positive for genetic alterations at each follow-up step to verify their association with prognosis and response to targeted therapies.

Study Timeline

• Study Start: 2018-06-12
• Primary Completion: 2023-01-31
• Study Completion: 2023-09-14
• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• patients with diagnosis of NSCLC
• patients candidates for mutational status assessment

Exclusion Criteria

• patients with age <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiomic signature	Radiomic signature	Assessment of radiomic signature and tumor genetic profile at baseline

Primary Outcome Measures

Name	Time	Method
Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status	1 month	The status of EGFR, ALK, KRAS will be validated for its association with nodal status at surgery
Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS)	5 years	Number of patiens with EGFR, ALK, KRAS mutations with an oncological event (local or distant) during follow up
Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS)	5 years	Number of patiens with EGFR, ALK, KRAS mutations alive at five years

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy