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
1 other identifier
observational
1,000
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
September 2, 2025
August 1, 2025
2.6 years
October 4, 2023
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Distribution of histologic subtypes
The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer
24 months
Secondary Outcomes (3)
Distribution of histologic subtypes according to clinical and radiological characteristics
24 months
Molecular profiling
24 months
Time to diagnosis
24 months
Interventions
Evaluation of the demographic, clinical, histological and molecular characteristics of advanced lung cancer at the time of Diagnosis
Eligibility Criteria
Consecutive, treatment-naïve, patients with clinical and radiological suspicion of advanced lung cancer referred for the initial diagnosis/staging/molecular profiling.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Interventional Pulmonology Division - Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Istituto Nazionale Tumori Regina Elena
Roma, Italy
Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rocco Trisolini
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 10, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
September 2, 2025
Record last verified: 2025-08