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

NCT05706883 | Completed

• 1 other identifier: 5394
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK

  2 months

• Tumor proportion score of PD-L1

  2 months

• Prevalence of cervical/supraclavicular lymph node metastasis

  2 months

• Predictors of cervical/supraclavicular lymph node metastasis

  6 months

Study Arms (2)

Experimental group

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

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

Control group

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

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

Interventions

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

Also known as: Ultrasound guided biopsy

Experimental group

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

Also known as: Ultrasound guided biopsy, Forceps biopsy during bronchoscopy, Surgical biopsy

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with clinical and radiological suspicion of advanced lung cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Location

MeSH Terms

Interventions

Needles; Surgical Instruments

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Surgical Equipment

Study Officials

• Rocco Trisolini, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 31, 2023
• Study Start: January 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 5, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)