NSCLCNCT07325864
Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site
An observational study of NSCLC and Lung Cancer (Diagnosis), run by European Institute of Oncology at 1 site in Italy.
Trial summary
investigate the molecular differences between primitive lung cancer and the metastatic site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Lung Cancer (Diagnosis)
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 18 Dec 2025to 31 Dec 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient diagnosed with NSCLC
Who may be able to join
- patients aged ≥18 years fit enough to tolerate the surgical operation;
- the operative risk is considered low based on respiratory reserve and cardiac assessment;
- the patient has clearly expressed willingness to adhere;
- availability of pathological material for tumor DNA extraction and NGS execution.
Who cannot join
- Women of childbearing age, pregnant or breastfeeding, or intending to become pregnant during the study.
- Any other illness, metabolic disorder, physical examination, or laboratory findings that constitute a contraindication to study participation.
- Recent or ongoing severe or clinically significant infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Europeo di Oncologia
Milan
Luca Bertolaccini, +390257489244, luca.bertolaccini@ieo.it
About this study
investigate the molecular differences between primitive lung cancer and the metastatic site.
- Conditions
- NSCLC, Lung Cancer (Diagnosis)
- Keywords
- lung cancer, nsclc, NGS, pleural metastasis, oligometastatic
- Medical subject headings
- Lung Neoplasms, Disease, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site in patient diagnosed with NSCLC | To investigate the molecular differences between primitive lung cancer and the metastatic site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the molecular differences between primitive lung cancer and the metastatic site.
Tumoral DNA will be extracted from the formalin-fixed paraffin-embedded (FFPE) block containing the highest percentage of tumor cells, with macrodissection, if necessary, to obtain at least 30% of tumor cells. DNA was extracted from FFPE samples. Next-generation sequencing (NGS) analysis will be performed as previously described. Gene amplification is defined by a coverage mean superior to 3SD.
Measured: From baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start18 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Spaggiari, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325864
- Sponsor's protocol ID
- UID 4058
- Other IDs
- IEO 1956
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site
- ClinicalTrials.gov ID
- NCT07325864
- Acronym / sponsor ID
- UID 4058
- Conditions
- NSCLC, Lung Cancer (Diagnosis)
- Keywords
- lung cancer, nsclc, NGS, pleural metastasis, oligometastatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jan 2026 (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.
investigate the molecular differences between primitive lung cancer and the metastatic site.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site in patient diagnosed with NSCLC | – | –To investigate the molecular differences between primitive lung cancer and the metastatic site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with NSCLC
Key inclusion criteria (4 listed)
- patients aged ≥18 years fit enough to tolerate the surgical operation;
- the operative risk is considered low based on respiratory reserve and cardiac assessment;
- the patient has clearly expressed willingness to adhere;
- availability of pathological material for tumor DNA extraction and NGS execution.
Key exclusion criteria (3 listed)
- Women of childbearing age, pregnant or breastfeeding, or intending to become pregnant during the study.
- Any other illness, metabolic disorder, physical examination, or laboratory findings that constitute a contraindication to study participation.
- Recent or ongoing severe or clinically significant infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the molecular differences between primitive lung cancer and the metastatic site.
Time frame: From baseline to 18 months
Tumoral DNA will be extracted from the formalin-fixed paraffin-embedded (FFPE) block containing the highest percentage of tumor cells, with macrodissection, if necessary, to obtain at least 30% of tumor cells. DNA was extracted from FFPE samples. Next-generation sequencing (NGS) analysis will be performed as previously described. Gene amplification is defined by a coverage mean superior to 3SD.
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 8 Jan 2026.
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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.
Lorenzo Spaggiari principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC and Lung Cancer (Diagnosis), run by European Institute of Oncology at 1 site 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 4 inclusion and 3 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Luca Bertolaccini (+390257489244, luca.bertolaccini@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the molecular differences between primitive lung cancer and the metastatic site. (time frame: From baseline to 18 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 8 Jan 2026.