Radiomics and Radiogenomics of Non-small Cell Lung Cancer

March 18, 2024 updated by: European Institute of Oncology

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

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

  • Italy
      • Milan, Italy
        • European Institute of Oncology

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

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

- patients with age <18 years

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Radiomic signature
Assessment of radiomic signature and tumor genetic profile at baseline
Diagnostic test: Radiomic signature
Assessment of radiomic signature and tumor genetic profile in patients with Non Small Cell Lung Cancer (NSCLC)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Francesca Botta, European Institute of Oncology

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)

June 12, 2018

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

September 14, 2023

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 0836

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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