UH-CAN Lung: Urine Home Collection for Lung Cancer Risk Assessment in Lung Cancer Screening Non-Responders – an observational, feasibility study protocol

<ns5:p>Early diagnosis of lung cancer leads to improved survival by detecting the disease at a more limited stage, allowing for more effective and potentially curative treatment options. The NHS England Lung Cancer Screening Programme (LCS) has significantly improved the rate of early-stage lung cancer diagnosis in those attending appointments. However, the uptake of LCS appointments varies considerably across England, averaging at 49%. Several barriers to participation were identified, including travel and fear of additional tests. The UH-CAN Lung study, developed by Cancer Research UK’s Southampton Clinical Trial Unit and funded by The Jon Moulton Charity Trust, was designed to investigate whether home collection of urine is a convenient and acceptable alternative method of exploring cancer risk for LCS non-responders. UH-CAN Lung is a non-interventional feasibility study that will post 1000 home urine collection kits to LCS non-responders. A short questionnaire with multiple-choice answers was developed and included with the kits to elicit further information about participant preferences around home sampling and reasons for LCS non-attendance. Participants will be asked to return their consent form, urine sample and questionnaire for processing and storage. At the end of the sample collection period, an aliquot of each sample is transferred to Elypta AB for quality evaluation and glycosaminoglycan profiling (GAGome), which is under investigation as a biomarker to improve the early detection of multiple cancers. Aggregate information on the number of samples returning a positive result will be returned to the study team to report alongside the sample return rate and information on whether invited participants go on to book an LCS appointment. This feasibility study will guide the design of a larger trial to generate evidence for the evaluation of both home urine collection for participant engagement and Elypta GAGome as a biomarker in the context of lung cancer screening.</ns5:p>