Lung Cancer Stage IV Clinical Trial
Official title:
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
| NCT number | NCT06076005 |
| Other study ID # | 5937 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 1, 2023 |
| Est. completion date | October 31, 2025 |
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.
| Status | Recruiting |
| Enrollment | 1000 |
| Est. completion date | October 31, 2025 |
| Est. primary completion date | June 30, 2025 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Distribution of histologic subtypes | The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer | 24 months | |
| Secondary | 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 | |
| Secondary | Molecular profiling | Prevalence of individual molecular markers in patients with advanced non-squamous non-small cell lung cancer histology | 24 months | |
| Secondary | Time to diagnosis | Time lag between onset of symptoms (if any) and invasive testing | 24 months |
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