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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Cancer, Supraclavicular Lymphadenopathy

Intervention / Treatment
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* Diagnostic Test: lower neck CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No neck CT<br>Cohort of patients with suspected lung cancer where the lower neck is not routinely included in CT | Diagnostic Test: lower neck CT<br>* Computerised tomography of the lower neck done as part of initial CT thorax and lower abdomen<br>|
| Neck CT<br>Cohort of patients with suspected lung cancer where the lower neck is routinely included in CT | Diagnostic Test: lower neck CT<br>* Computerised tomography of the lower neck done as part of initial CT thorax and lower abdomen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of pathologically confirmed malignant supraclavicular lymph node | 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 | 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 |  | 60 days from initial CT Thorax | 
| Proportion of patients who underwent Endobronchial Ultrasound (EBUS) |  | 60 days from initial CT Thorax |