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Completed

NCT Number: NCT03970564

Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer

This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer

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Key information

Conditions

Lung Cancer Metastatic Hemic and Lymphatic Diseases Lung Diseases Lung Neoplasms Lymphadenopathy Lymphatic Diseases Neoplasms Neoplasms by Site Nodes, Lung Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Study type

Observational

Primary location

University Hospital Galway

Galway, Ireland

About this study

In the first phase of the study a respiratory physician was trained to perform neck ultrasound and needle sampling of enlarged cervical lymph nodes according to preset criteria. In the second phase patients with suspected lung cancer and enlarged mediastinal lymph nodes underwent routine neck ultrasound and enlarged cervical lymph nodes were sampled using fine needle and or core needle biopsy.

The outcomes of interest in the study were the rate of malignant cervical lymphadenopathy defined as pathological evidence of cancer in neck lymph node samples consistent with a lung primary, adequacy of needle sampling, patient reported experience assessed by a visual analogue of discomfort associated with needle neck sampling and EBUS, and the proportion of patients that had nodal upstaging

Who can participate

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

Inclusion criteria

  • Suspected and later on confirmed lung cancer
  • Presence of at least one mediastinal lymph node measuring > 10 mm in short diameter on computerised Tomography

Exclusion criteria

  • Age <18
  • History any malignancy apart from non-melanomatous skin cancer
  • Inability to give informed consent

Treatment and study plan

Neck ultrasound guide lymph node sampling

Diagnostic Test

Neck ultrasound done first and lymph nodes larger than 5 mm that are technically feasible are sampled using fine needle aspiration and/or core needle biopsy

Primary outcomes

  1. Adequacy of lymph node sampling

    Time frame: 7 days

    Presence of lymphocytes or malignant cells in biopsy samples

Secondary outcomes

  1. Proportion of patients with malignant cervical lymphadenopathy

    Time frame: 7 days

    Presence of malignant cells consistent with lung cancer in cervical lymph node samples

  2. Proportion of patients with nodal status upstaged

    Time frame: 7 days

    Defined as a change from cN2 to cN3 according to the 8th edition of the Tumour Node Metastasis TNM staging system

Sponsors and collaborators

Lead sponsor

University College Hospital Galway

Other

Collaborators

  • European Respiratory Society

Registry information

Official study title

Routine Neck Ultrasound by Respiratory Physicians in the Diagnosis and Staging of Patients With Lung Cancer and Mediastinal Lymphadenopathy, a Prospective Pilot Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 31, 2019
Registry last updated
May 31, 2019

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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