Molecular profiling of primary lung cancer and its metastatic site
Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site
This project will compare the DNA of a person’s primary non-small cell lung tumor and a matching metastatic lesion using next-generation sequencing to see if they differ.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07325864 on ClinicalTrials.gov |
What this trial studies
This observational study collects matched tissue samples from primary non-small cell lung tumors and their metastatic sites and performs tumor DNA next-generation sequencing. The plan is to compare genomic and molecular differences between the two locations to characterize divergence and potential actionable targets. Eligible participants are adults who can safely undergo the planned surgical procedure and can provide sufficient tumor tissue for sequencing. Standard exclusions include pregnancy or breastfeeding, significant active infections, or other medical contraindications to participation.
Who should consider this trial
Good fit: Adults (18 or older) with NSCLC who are fit for the planned surgery and can provide sufficient tumor tissue for DNA sequencing are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have active severe infections, have high operative risk, or lack available tumor tissue are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help doctors choose more precise targeted therapies by revealing genetic differences between primary and metastatic tumors.
How similar studies have performed: Prior sequencing studies in lung cancer have frequently found genetic differences between primary tumors and metastases, so this approach builds on established evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Milan
- Istituto Europeo di Oncologia — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Lorenzo Spaggiari — European Institute of Oncology
- Study coordinator: Luca Bertolaccini
- Email: luca.bertolaccini@ieo.it
- Phone: +390257489244
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.