NCT05706883

Clinical and Molecular Findings in Patients With Cervical/Supraclavicular Metastasis From Non-small-cell Lung Cancer (NSCLC)

Mutational Profile of Patients With and Without Neck and Supraclavicular Lymph Nodes Metastasis From Advanced Non-squamous Non-small-cell Lung Cancer: a Prospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 348 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites.

Conditions

• Lung Cancer Metastatic

Interventions

Type	Name	Description
PROCEDURE	Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes	Patients with evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes suspected of being metastasis from lung cancer will be submitted to the biopsy from this location.
PROCEDURE	Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes	Patients without evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes will be submitted to the biopsy considered less invasive and effective based on imaging data and clinical health status.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-09-30
• Completion: 2023-11-30
• First posted: 2023-01-31
• Last updated: 2024-04-05

Locations

1 site across 1 country: Italy