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.
Study Type
OBSERVATIONAL
Enrollment
348
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.
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Prevalence of KRAS mutation
Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
Time frame: 2 months
Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK
Number of participants with EGFR, ALK, ROS1, BRAF, RET, MET, NTRK mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
Time frame: 2 months
Tumor proportion score of PD-L1
Number of participants with a tumor proportion score of PD-L1 \< 1%; 1-50%; \>50% in the two groups (patients with and without cervical/supraclavicular lymph node metastasis)
Time frame: 2 months
Prevalence of cervical/supraclavicular lymph node metastasis
Number of participants with cervical/supraclavicular lymph node metastasis in the whole cohort of patients with stage IV lung cancer
Time frame: 2 months
Predictors of cervical/supraclavicular lymph node metastasis
Association between the presence of cervical/supraclavicular lymph node metastasis and the following factors: age, sex, smoking habit, tumor histologic type, central vs peripheral primary tumor, enlarged and/or PET positive N2 or N3 lymph nodes in the middle mediastinum, and molecular profile.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.