Study of characteristics in advanced lung cancer patients in Italy
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06076005
This study looks at the different traits and features of patients with advanced lung cancer in Italy to better understand their condition at the time of diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 3 sites (Roma and 2 other locations) |
| Trial ID | NCT06076005 on ClinicalTrials.gov |
What this trial studies
This observational study aims to systematically assess the demographic, clinical, radiological, pathological, and molecular characteristics of patients diagnosed with Stage IV lung cancer in Italy. It will involve a large cohort of consecutive patients referred to two tertiary referral centers. The study seeks to identify preferential associations between various characteristics at the time of diagnosis, which have not been specifically studied in this population before.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have a suspicion of lung cancer based on imaging and require a biopsy for diagnosis or molecular profiling.
Not a fit: Patients with early-stage lung cancer (TNM Stage I-III) or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of lung cancer characteristics, leading to improved diagnosis and treatment strategies for patients.
How similar studies have performed: While similar studies have been conducted in other regions, this specific assessment of advanced lung cancer characteristics in Italy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Roma and 2 other locations
- Interventional Pulmonology Division - Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (RECRUITING)
- Istituto Nazionale Tumori Regina Elena — Roma, Italy (NOT_YET_RECRUITING)
- Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Rocco Trisolini — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Rocco Trisolini, MD
- Email: rocco.trisolini@policlinicogemelli.it
- Phone: 0630154163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancer Stage IV