Clinical trial · Observational
Clinical and Molecular Findings in Patients With Cervical/Supraclavicular Metastasis From Non-small-cell Lung Cancer (NSCLC)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes | Procedure | — | UNRESOLVED |
| Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Experimental group
- description
- Patients with advanced lung cancer featuring cervical and/or supraclavicular lymph node metastasis
- interventionNames
- Procedure: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes
- label
- Control group
- description
- Patients with advanced lung cancer NOT featuring cervical and/or supraclavicular lymph node metastasis
- interventionNames
- Procedure: Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes
Primary outcomes (1)
- measure
- Prevalence of KRAS mutation
- timeFrame
- 2 months
- description
- Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available