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RecruitingNCT06076005LUNG-CANCERUpdated Sep 2, 2025

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

An observational study in Lung Cancer Stage IV, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer Stage IV

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Interventions

  • OtherAdvanced lung cancer patients' group

    Evaluation of the demographic, clinical, histological and molecular characteristics of advanced lung cancer at the time of Diagnosis

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What researchers measure

Primary outcomes

  1. Distribution of histologic subtypes

    The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer

    Time frame: 24 months

Secondary outcomes

  1. 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

    Time frame: 24 months

  2. Molecular profiling

    Prevalence of individual molecular markers in patients with advanced non-squamous non-small cell lung cancer histology

    Time frame: 24 months

  3. Time to diagnosis

    Time lag between onset of symptoms (if any) and invasive testing

    Time frame: 24 months

07

Study locations

1 of 3 sites recruiting
  • Interventional Pulmonology Division - Fondazione Policlinico Universitario A. Gemelli IRCCS
    Roma, Italy
    Recruiting
  • Istituto Nazionale Tumori Regina Elena
    Roma, Italy
    • Federico Cappuzzo, MD · Contact
    Not yet recruiting
  • Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Roma, Italy
    • Emilio Bria · Contact
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06076005
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Oct 10, 2023
Start date
Nov 1, 2023
Primary completion
May 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Sep 2, 2025

Study contacts

Rocco Trisolini, MD
Contact
rocco.trisolini@policlinicogemelli.it
0630154163
Rocco Trisolini
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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