Radiomics and Radiogenomics of Non-small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

Radiomics and Radiogenomics of Non-small Cell Lung Cancer: Relationships of Radiomic Signature With Gene Driver Mutations and Implications for Emerging Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06331975
• Other study ID #: IEO 0836
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: September 14, 2023

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 14, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with diagnosis of NSCLC

• patients candidates for mutational status assessment

Exclusion Criteria:

• patients with age <18 years

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Diagnostic Test:
• Radiomic signature
Assessment of radiomic signature and tumor genetic profile in patients with Non Small Cell Lung Cancer (NSCLC)

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The status of EGFR, ALK, KRAS will be validated for its association with nodal status at surgery	1 month
Primary	Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS)	Number of patiens with EGFR, ALK, KRAS mutations alive at five years	5 years
Primary	Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS)	Number of patiens with EGFR, ALK, KRAS mutations with an oncological event (local or distant) during follow up	5 years