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

Lung Cancer Metastatic Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706883
• Other study ID #: 5394
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer Metastatic
• Lung Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of KRAS mutation	Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)	2 months
Secondary	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)	2 months
Secondary	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)	2 months
Secondary	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	2 months
Secondary	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.	6 months