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Title

UrineÌýHome Collection for LungÌýCancer Risk Assessment in TargetedÌýLungÌýHealth Check Non-Responders (UH-CAN LUNG)

Description

Lung cancer is the most common cause of cancer death in the UK causing more than 95 deaths per day. Sadly, many cases are diagnosed too late, when the cancer has already spread and can no longer be cured. More than three quarters of lung cancer diagnoses in the UK are predicted to be preventable with two of the major risk factors being age and smoking, with 72% of cases occurring in patients with a smoking history.

Earlier diagnosis of cancer improves the chance of cure by identifying disease at an earlier stage where treatment options are more effective. That’s why, in 2019, NHS England launched the Targeted Lung Health Check programme, now called the Lung Cancer Screening (LCS) programme, as part of its Long Term Plan to improve early cancer diagnosis and survival. It targets people with a smoking history, aged 55 to 74 years old, who are most at risk of developing lung cancer. At the time of writing more than 1.5 million people have invited to participate in a LCS in England, Unfortunately, more than half of those invited do not respond. Screening can only help if people take part, so improving participation is key.

One possible solution is using urine samples for testing, which has already been shown to be an acceptable sampling method for other. There is, however, very limited data on the uptake rate in non-responding cancer screening cohorts.

UH-CAN LUNG is a feasibility study to understand if LCS non-responders will be willing to return a urine sample collected at home to be analysed as part of a laboratory test. To test this, 1,000 non-responders will be sent a urine collection kit over a five-month period. Sampling kits will also include a short participant questionnaire to understand how easy a urine home collection kit was to use and whether this is an acceptable form of test, as well as reasons they did not engage originally with the LCS programme.

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Objectives

Primary:

• Evaluate whether self-administered home collection of a urine sample for MCED testing represents a feasible alternative option for engaging individuals at increased risk of lung cancer who fail to respond to a LCS invitation (LCS non-responders).

Secondary:

• Evaluate the proportion of LCS non-responders who return a self-administered home urine kit for cancer screening.
• Evaluate the proportion of LCS non-responders invited to provide a self-administered home urine sample would go on to book a screening assessment for a LCS programme.
• Evaluate the proportion of LCS non-responders subsequently found to be eligible for LDCT screening when later responding to the LCS programme.
• Understand the proportion of participants who have a LDCT scan that are diagnosed with a suspected lung cancer.
• Participant reported measures of utilising a self-administered urine home collection test kit including ease and acceptability.
• Evaluate participant reasoning for non-engagement with the LCS programme.

Tertiary:

• Estimated cancer risk as assessed by a urine MCED test in LCS non-responders.

Trial Design:

UH-CAN LUNG is a non-interventional feasibility study to evaluate whether home-based self-collection of a urine sample may provide a viable option to improve engagement with the national LCS programme in individuals who are eligible for screening but fail to respond. We will send out 1000 sampling kits to LCS non-responders over a period of 5 months.

Trial Status:

In set-up

Population:

People aged 55-74 years with a smoking history who fail to respond to the LCS invitation (termed LCS non-responders).

Funder:

This trial is primarily funded by the John Moulton Charity Trust with contributions for some staff costs from CRUK core funding for SCTU.