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

April 30, 2018 updated by: Mohammed Ahmed, University College Hospital Galway
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients initially seen with suspected lung cancer

Description

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:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Computerised tomography of the lower neck done as part of initial CT thorax and lower abdomen
Neck CT
Cohort of patients with suspected lung cancer where the lower neck is routinely included in CT
Diagnostic test: lower neck CT
Computerised tomography of the lower neck done as part of initial CT thorax and lower abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of pathologically confirmed malignant supraclavicular lymph node
Time Frame: 60 days from initial CT
evidence of malignancy consistent with lung cancer on fine needle aspiration or core biopsy
60 days from initial CT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of diagnostic procedures performed per patient
Time Frame: 60 days from initial CT Thorax
number of invasive procedures used to obtain tissue to achieve diagnosis and/or stage
60 days from initial CT Thorax
Proportion of patients who underwent more than one diagnostic procedures
Time Frame: 60 days from initial CT Thorax
60 days from initial CT Thorax
Proportion of patients who underwent Endobronchial Ultrasound (EBUS)
Time Frame: 60 days from initial CT Thorax
60 days from initial CT Thorax

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Hospital Galway

Collaborators

University Hospital Plymouth NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

January 30, 2019

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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