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Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970564
Recruitment Status : Completed
First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
European Respiratory Society
Information provided by (Responsible Party):
Mohammed Ahmed, University College Hospital Galway

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

Condition or disease Intervention/treatment
Lung Cancer Metastatic Nodes, Lung Diagnostic Test: Neck ultrasound guide lymph node sampling

Detailed Description:

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

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Routine Neck Ultrasound by Respiratory Physicians in the Diagnosis and Staging of Patients With Lung Cancer and Mediastinal Lymphadenopathy, a Prospective Pilot Study
Actual Study Start Date : October 21, 2016
Actual Primary Completion Date : May 21, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Suspected lung cancer
Suspected and later on confirmed lung cancer with evidence of mediastinal lymphadenopathy on computerised tomography
Diagnostic Test: Neck ultrasound guide lymph node sampling
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 Outcome Measures :
  1. Adequacy of lymph node sampling [ Time Frame: 7 days ]
    Presence of lymphocytes or malignant cells in biopsy samples


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected and later on confirmed lung cancer with evidence of enlarged mediastinal lymph node(s) measuring > 10 mm in short diameter on Computerised Tomography
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970564


Locations
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Ireland
University Hospital Galway
Galway, Ireland
Sponsors and Collaborators
University College Hospital Galway
European Respiratory Society

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Responsible Party: Mohammed Ahmed, Clinical fellow, University College Hospital Galway
ClinicalTrials.gov Identifier: NCT03970564    
Other Study ID Numbers: Version 01
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed Ahmed, University College Hospital Galway:
ultrasound
lymphadenopathy
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Lymphadenopathy
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lymphatic Diseases