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

Completed

• Conditions: Lung Cancer Metastatic
• Interventions: Procedure: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes; Procedure: Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes

• Registration Number: NCT05706883
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-31
• Primary Completion: 2023-09-30
• Study Completion: 2023-11-30
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

• Age >18 years at the time of the procedure;
• Suspected advanced, treatment naïve non-squamous NSCLC ;
• Indication to biopsy for diagnosis and/or molecular profiling;
• Written informed consent to the study participation.

Exclusion Criteria

• Patients with known non-squamous NSCLC sent for re-biopsy after first or second line treatment;
• Inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day);
• Platelet count <50.000 per μL;
• Inability or unwillingness to provide a written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes	Patients with advanced lung cancer featuring cervical and/or supraclavicular lymph node metastasis
Control group	Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes	Patients with advanced lung cancer NOT featuring cervical and/or supraclavicular lymph node metastasis

Primary Outcome Measures

Name	Time	Method
Prevalence of KRAS mutation	2 months	Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)

Secondary Outcome Measures

Name	Time	Method
Tumor proportion score of PD-L1	2 months	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)
Prevalence of cervical/supraclavicular lymph node metastasis	2 months	Number of participants with cervical/supraclavicular lymph node metastasis in the whole cohort of patients with stage IV lung cancer
Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK	2 months	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)
Predictors of cervical/supraclavicular lymph node metastasis	6 months	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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy