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出境医 / 临床实验 / Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer

Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
Ireland
University Hospital Galway
Galway, Ireland
Sponsors and Collaborators
University College Hospital Galway
European Respiratory Society
Tracking Information
First Submitted Date May 29, 2019
First Posted Date May 31, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date October 21, 2016
Actual Primary Completion Date May 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2019) 		Adequacy of lymph node sampling [ Time Frame: 7 days ]
Presence of lymphocytes or malignant cells in biopsy samples
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 29, 2019)
  • Proportion of patients with malignant cervical lymphadenopathy [ Time Frame: 7 days ]
    Presence of malignant cells consistent with lung cancer in cervical lymph node samples
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer
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
Brief Summary This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Lung Cancer Metastatic
  • Nodes, Lung
Intervention 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
Study Groups/Cohorts Suspected lung cancer
Suspected and later on confirmed lung cancer with evidence of mediastinal lymphadenopathy on computerised tomography
Intervention: Diagnostic Test: Neck ultrasound guide lymph node sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 29, 2019) 		30
Original Actual Enrollment Same as current
Actual Study Completion Date May 30, 2018
Actual Primary Completion Date May 21, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03970564
Other Study ID Numbers Version 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mohammed Ahmed, University College Hospital Galway
Study Sponsor University College Hospital Galway
Collaborators European Respiratory Society
Investigators Not Provided
PRS Account University College Hospital Galway
Verification Date May 2019

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