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

NCT ID: NCT03522090

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-01-30

Brief 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.

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.

Conditions

Lung Cancer; Supraclavicular Lymphadenopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

No neck CT

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

lower neck CT

Intervention Type: DIAGNOSTIC_TEST

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

lower neck CT

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

lower neck CT

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: collaborator

University College Hospital Galway

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Ahmed

Fellow in interventional respiratory medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohammed Ahmed, Dr

Role: CONTACT

jamaleldeen@gmail.com

0035391524222

Other Identifiers

V1.0

Identifier Type: -

Identifier Source: org_study_id