Lung Cancer ID (Identity) Study

Recruiting

• Conditions: Lung Cancer Stage IV

• Registration Number: NCT06076005
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Study Start: 2023-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of histologic subtypes	24 months	The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy

Interventional Pulmonology Division - Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy

Istituto Nazionale Tumori Regina Elena; 🇮🇹 Roma, Italy