Recruiting NCT06180005

Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D.)

— Observational Non Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Non Small Cell Lung Cancer. Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D)

Overview

According to an analysis by Memorial Sloan Kettering Cancer Center patients who receive a target therapy having an oncogenic driver mutation live longer than those who do not receive it. In addition to that, therapies guided by analysis on mutations identified in ct-DNA had a favorable impact, allowing longer survival. All this suggests that the presence of a therapeutically targetable oncogene (oncogene addicted) allows target therapy, resulting in a longer life expectancy. The main objective of this study is to evaluate the frequency of patients with oncogene addiction in a consecutive series of patients with NSCLC afferent to the CRO. Oncogene addiction is defined as being carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET or other mutations that become therapeutic targets under investigation.

Detailed description

Primary outcome measures

To evaluate the frequency of patients with oncogene addiction in a consecutive series of patients afferent to the CRO with NSCLC. [Time frame: up to 15 years]

Secondary outcome measures (7)

Frequency of mutations according to tumor histotype (squamous and nonsquamous) [Time frame: up to 15 years]
Evaluate trend of mutations over time [Time frame: up to 15 years]
Compare PFS in new patients with and without oncogene addiction [Time frame: up to 15 years]
Compare OS in new patients with and without oncogene addiction [Time frame: up to 15 years]
Assess OS in different mutation types, stratifying by histotype [Time frame: up to 15 years]
Assess PFS in different mutation types, stratifying by histotype [Time frame: up to 15 years]
Assess the frequency of different types of molecular alterations and possible new target alterations [Time frame: up to 15 years]

Eligibility criteria

Inclusion criteria

First visit or first admission to CRO occurred in the period from September 2023 to September 2028
Diagnosis of NSCLC any stage

Exclusion criteria

\- Diagnosis of tumor not of certain lung origin (uncertain origin)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Italy · 1 center

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano

Identifiers

NCT: NCT06180005 · CRO-2023-38

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗