An observational study in Lung Cancer Metastatic, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 348 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Patients with clinical and radiological suspicion of advanced lung cancer
Exclusion Criteria:
Patients with advanced lung cancer featuring cervical and/or supraclavicular lymph node metastasis
Procedure: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes
Patients with advanced lung cancer NOT featuring cervical and/or supraclavicular lymph node metastasis
Procedure: Needle, forceps or surgical biopsy of any lesion other than 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.
Also known as: Ultrasound guided biopsy
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.
Also known as: Ultrasound guided biopsy, Forceps biopsy during bronchoscopy, Surgical biopsy
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
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS