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OpenTrials
Completed

NCT Number: NCT05706883

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

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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Key information

Conditions

Lung Cancer Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ultrasound guided biopsy

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.

Other names: Ultrasound guided biopsy, Forceps biopsy during bronchoscopy, Surgical biopsy

Primary outcomes

  1. Prevalence of KRAS mutation

    Time frame: 2 months

    Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)

Secondary outcomes

  1. Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK

    Time frame: 2 months

    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. Tumor proportion score of PD-L1

    Time frame: 2 months

    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)

  3. Prevalence of cervical/supraclavicular lymph node metastasis

    Time frame: 2 months

    Number of participants with cervical/supraclavicular lymph node metastasis in the whole cohort of patients with stage IV lung cancer

  4. Predictors of cervical/supraclavicular lymph node metastasis

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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

Acronym: ProphetaPro

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2023
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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