NCT03970564

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

May 29, 2019

Last Update Submit

May 29, 2019

Conditions

Lung Cancer MetastaticNodes, Lung

Keywords

ultrasoundlymphadenopathylung cancer

Outcome Measures

Primary Outcomes (1)

  • Adequacy of lymph node sampling

    Presence of lymphocytes or malignant cells in biopsy samples

    7 days

Secondary Outcomes (2)

  • Proportion of patients with malignant cervical lymphadenopathy

    7 days

  • Proportion of patients with nodal status upstaged

    7 days

Study Arms (1)

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

Interventions

Neck ultrasound guide lymph node samplingDIAGNOSTIC_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

Suspected lung cancer

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Galway

Galway, Ireland

Location

MeSH Terms

Conditions

LymphadenopathyLung Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical fellow

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

October 21, 2016

Primary Completion

May 21, 2018

Study Completion

May 30, 2018

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)