Lung Cancer Stage IVLUNG-CANCERNCT06076005
Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohor
An observational study of Lung Cancer Stage IV, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Stage IV
- What is being tested?
- Advanced lung cancer patients' group
- How many people
- 1,000 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive, treatment-naïve, patients with clinical and radiological suspicion of advanced lung cancer referred for the initial diagnosis/staging/molecular profiling.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Interventional Pulmonology Division - Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
Marta Viscuso, MD, marta.viscuso@guest.policlinicogemelli.it
- Not yet recruiting
Istituto Nazionale Tumori Regina Elena
Roma
Federico Cappuzzo, MD
- Not yet recruiting
Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Emilio Bria
About this study
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
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.
- Conditions
- Lung Cancer Stage IV
- Being tested
- Advanced lung cancer patients' group
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced lung cancer patients' groupOther
Evaluation of the demographic, clinical, histological and molecular characteristics of advanced lung cancer at the time of Diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of histologic subtypes
The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer
Measured: 24 months
Secondary outcomes (3)
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
Measured: 24 months
Molecular profiling
Prevalence of individual molecular markers in patients with advanced non-squamous non-small cell lung cancer histology
Measured: 24 months
Time to diagnosis
Time lag between onset of symptoms (if any) and invasive testing
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Nov 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocco Trisolini, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076005
- Sponsor's protocol ID
- 5937
- Acronym
- LUNG-CANCER
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06076005
- Acronym / sponsor ID
- LUNG-CANCER / 5937
- Conditions
- Lung Cancer Stage IV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive, treatment-naïve, patients with clinical and radiological suspicion of advanced lung cancer referred for the initial diagnosis/staging/molecular profiling.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced lung cancer patients' groupEvaluation of the demographic, clinical, histological and molecular characteristics of advanced lung cancer at the time of Diagnosis | Other | – |
Primary outcome
Distribution of histologic subtypes
Time frame: 24 months
The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer
3 secondary outcomes
Distribution of histologic subtypes according to clinical and radiological characteristics
Time frame: 24 months
Molecular profiling
Time frame: 24 months
Time to diagnosis
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rocco Trisolini principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Stage IV, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rocco Trisolini, MD (0630154163, rocco.trisolini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of histologic subtypes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.