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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

Patients with advanced lung cancer featuring cervical and/or supraclavicular lymph node metastasis

Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes

Intervention Type PROCEDURE

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.

Control group

Patients with advanced lung cancer NOT featuring cervical and/or supraclavicular lymph node metastasis

Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound guided biopsy Ultrasound guided biopsy Forceps biopsy during bronchoscopy Surgical biopsy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No