CClinicalTrials.gg
Status unknownNCT03522090Updated May 11, 2018

Retrospective Comparative Study of Routine Lower Neck CT in the Staging and Diagnosis of Lung Cancer Across Two Cohorts

An observational study in Lung Cancer and Supraclavicular Lymphadenopathy, sponsored by University College Hospital Galway. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-11.

Sponsored by University College Hospital Galway · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
164
Ages
18 Years and older
Sex
All
01

Study summary

This is a study comparing routine inclusion of the lower neck in initial CT thorax in patients with suspected lung cancer to not including it. The study aims to assess whether such an intervention reduces the number of invasive investigations required to achieve a final diagnosis and clinical stage and whether it improves the detection of cervical lymph nodes involvement by lung cancer.

Read the detailed description

Two practices currently exist regarding the role of lower neck CT in patients with suspected lung cancer but with little evidence for either. Routine lower neck CT is potentially associated with benefits of higher detection of neck lymphadenopathy leading to better staging, less invasive procedure with positive implications for patients experience and care. The potential harms are delay in diagnosis due to false positive findings and radiation exposure. There is limited evidence in this area so this study will potentially provide evidence to inform health policy decisions based on the risk benefit balance.

This is a retrospective comparative study to assess the real-life impact of routine lower neck CT on the diagnostic and staging work up of patients with suspected lung cancer across two cohorts.

02

Conditions studied

  • Lung Cancer
  • Supraclavicular Lymphadenopathy
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 164 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University College Hospital Galway is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients initially seen with suspected lung cancer

Inclusion criteria

  • Male or female age > 18 years
  • Pathologically confirmed primary lung cancer
  • Intrathoracic N2 and or N3 disease on CT defined as lymph node with short diameter > 10 mm

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
164 participants (estimated)
Patient registry
No

Groups and cohorts

  • No neck CT

    Cohort of patients with suspected lung cancer where the lower neck is not routinely included in CT

    Diagnostic Test: lower neck CT

  • Neck CT

    Cohort of patients with suspected lung cancer where the lower neck is routinely included in CT

    Diagnostic Test: lower neck CT

Interventions

  • Diagnostic testlower neck CT

    Computerised tomography of the lower neck done as part of initial CT thorax and lower abdomen

06

What researchers measure

Primary outcomes

  1. Proportion of pathologically confirmed malignant supraclavicular lymph node

    evidence of malignancy consistent with lung cancer on fine needle aspiration or core biopsy

    Time frame: 60 days from initial CT

Secondary outcomes

  1. Number of diagnostic procedures performed per patient

    number of invasive procedures used to obtain tissue to achieve diagnosis and/or stage

    Time frame: 60 days from initial CT Thorax

  2. Proportion of patients who underwent more than one diagnostic procedures

    Time frame: 60 days from initial CT Thorax

  3. Proportion of patients who underwent Endobronchial Ultrasound (EBUS)

    Time frame: 60 days from initial CT Thorax

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03522090
Lead sponsor
University College Hospital Galway
Collaborators
University Hospital Plymouth NHS Trust
Responsible party
Mohammed Ahmed (Fellow in interventional respiratory medicine, University College Hospital Galway) — Principal investigator
First posted
May 11, 2018
Start date
Jul 1, 2018 (estimated)
Primary completion
Dec 30, 2018 (estimated)
Completion
Jan 30, 2019 (estimated)
Last update
May 11, 2018

Study contacts

Mohammed Ahmed, Dr
Contact
jamaleldeen@gmail.com
0035391524222

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion