Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site

investigate the molecular differences between primitive lung cancer and the metastatic site.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Lung Cancer (Diagnosis)

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Luca Bertolaccini; Phone Number: +390257489244; Email: luca.bertolaccini@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Istituto Europeo di Oncologia
    • Contact: Luca Bertolaccini; Phone Number: +390257489244; Email: luca.bertolaccini@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with NSCLC

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 18 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Lorenzo Spaggiari, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer; NGS; nsclc; pleural metastasis; oligometastatic
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: UID 4058; IEO 1956 (Other Identifier: Comitato Etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No