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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03522090
• Other study ID #: V1.0
• Status: Not yet recruiting
• Start date: July 1, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: April 2018
• Source: University College Hospital Galway
• Contact: Mohammed Ahmed, Dr
• Phone: 0035391524222
• Email: jamaleldeen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: January 30, 2019
• Est. primary completion date: December 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Lymphadenopathy
• Supraclavicular Lymphadenopathy

Intervention

Diagnostic Test:
• lower neck CT
Computerised tomography of the lower neck done as part of initial CT thorax and lower abdomen

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University College Hospital Galway	University Hospital Plymouth NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of patients who underwent more than one diagnostic procedures		60 days from initial CT Thorax
Secondary	Proportion of patients who underwent Endobronchial Ultrasound (EBUS)		60 days from initial CT Thorax