Clinical trial NCT06180005: Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D.)
Official title: Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists of patients with NSCLC who are afferent to the CRO. All patients who give their consent to participate in the study.

Brief summary: 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: 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.

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)

Primary outcomes:
measure: To evaluate the frequency of patients with oncogene addiction in a consecutive series of patients afferent to the CRO with NSCLC.
timeFrame: up to 15 years
Secondary outcomes:
measure: Frequency of mutations according to tumor histotype (squamous and nonsquamous)
timeFrame: up to 15 years
measure: Evaluate trend of mutations over time
timeFrame: up to 15 years
measure: Compare PFS in new patients with and without oncogene addiction
timeFrame: up to 15 years
measure: Compare OS in new patients with and without oncogene addiction
timeFrame: up to 15 years
measure: Assess OS in different mutation types, stratifying by histotype
timeFrame: up to 15 years
measure: Assess PFS in different mutation types, stratifying by histotype
timeFrame: up to 15 years
measure: Assess the frequency of different types of molecular alterations and possible new target alterations
timeFrame: up to 15 years
Other outcomes:
measure: Assess the feasibility of developing Neural Language Processing (NLP) algorithms for the extraction of structured data from unstructured texts and verify the reliability of the results
timeFrame: up to 15 years
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
name: Alessandro Del Conte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS
name: Alessandra Bearz, MD
role: STUDY_DIRECTOR
References: