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

NCT06180005 | Recruiting

• 1 other identifier: CRO-2023-38
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the frequency of patients with oncogene addiction in a consecutive series of patients afferent to the CRO with NSCLC.

  Frequency of patients carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET

  up to 15 years

Secondary Outcomes (7)

• Frequency of mutations according to tumor histotype (squamous and nonsquamous)

  up to 15 years

• Evaluate trend of mutations over time

  up to 15 years

• Compare PFS in new patients with and without oncogene addiction

  up to 15 years

• Compare OS in new patients with and without oncogene addiction

  up to 15 years

• Assess OS in different mutation types, stratifying by histotype

  up to 15 years

Other Outcomes (1)

• 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

  up to 15 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alessandro Del Conte, MD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  PRINCIPAL INVESTIGATOR

• Alessandra Bearz, MD

  Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

  STUDY DIRECTOR

Central Study Contacts

Alessandro Del Conte, MD

CONTACT

0434 399464; alessandro.delconte@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 22, 2023
• Study Start: January 6, 2024
• Primary Completion (Estimated): January 2, 2039
• Study Completion (Estimated): December 30, 2039
• Last Updated: August 27, 2024

Record last verified: 2023-12

Locations

IT (1)