Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohor (LUNG-CANCER)

Demographic, Clinical, Histological and Molecular Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohort, an Observational Cohort Study: Lung Cancer ID Study

The distribution of demographic, clinical, radiological, pathological and molecular characteristics of lung cancer at the time of diagnosis, as well as preferential association between elements of those domains, have not been specifically studied in Italy. The aim of the present project is to assess, in a systematic fashion, the demographic, clinical, radiological, pathological and molecular characteristics of advanced lung cancer at the time of diagnosis in a large Italian cohort of consecutive patients referred to two tertiary referral centers.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer Stage IV
• Intervention / Treatment: Other: Advanced lung cancer patients' group

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Rocco Trisolini, MD; Phone Number: 0630154163; Email: rocco.trisolini@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy
    • Not yet recruiting
    • Istituto Nazionale Tumori Regina Elena
    • Contact: Federico Cappuzzo, MD
  • Roma, Italy
    • Recruiting
    • Interventional Pulmonology Division - Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Marta Viscuso, MD; Email: marta.viscuso@guest.policlinicogemelli.it
  • Roma, Italy
    • Not yet recruiting
    • Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: Emilio Bria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Consecutive, treatment-naïve, patients with clinical and radiological suspicion of advanced lung cancer referred for the initial diagnosis/staging/molecular profiling.

Description

Inclusion Criteria:

• Age >18 years
• Suspicion of lung cancer based on imaging (CT and/or PET/CT)
• Indication to a biopsy for diagnosis, staging and/or molecular profiling

Exclusion Criteria:

• Inability or unwillingness to provide a written informed consent
• ECOG performance status (>3) which makes a tissue diagnosis unfeasible
• ASA 4 status
• TNM Stage I-III

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of histologic subtypes	The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular profiling	Prevalence of individual molecular markers in patients with advanced non-squamous non-small cell lung cancer histology	24 months
Time to diagnosis	Time lag between onset of symptoms (if any) and invasive testing	24 months
Distribution of histologic subtypes according to clinical and radiological characteristics	The investigators will assess the prevalence of different histologic subtypes according to clinical and imaging characteristics	24 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Rocco Trisolini, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 5937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators will decide how to share the data at the end of the study upon reasonable request to be addressed to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No