Non Small Cell Lung Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTRadiomic signature
Assessment of radiomic signature and tumor genetic profile in patients with Non Small Cell Lung Cancer (NSCLC)
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with diagnosis of NSCLC * patients candidates for mutational status assessment
Exclusion criteria
\- patients with age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 overall survival (OS) | 5 years | Number of patiens with EGFR, ALK, KRAS mutations alive at five years |
| 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 |
Countries
Italy
Outcome results
None listed