Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site

NCT07325864 | Recruiting

• 2 other identifiers: UID 4058IEO 1956
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with NSCLC

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Istituto Europeo di Oncologia

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Lorenzo Spaggiari

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Bertolaccini

CONTACT

+390257489244; luca.bertolaccini@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 8, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

IT (1)