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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Lung Cancer Metastatic

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

Study type: Observational

Funder types: Other

Identifiers

NCT05706883

5394

Details and patient eligibility

About

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.

Enrollment: 348 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

348 participants in 2 patient groups

Experimental group

Description:

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

Treatment:

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

Control group

Description:

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

Treatment:

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