Optimising Colorectal Cancer Patient Pathways

Sponsor
University of Edinburgh
Study ID
NCT07430540
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Additional FIT testing — DIAGNOSTIC_TEST
    Additional (3) FIT tests

Study Details

Bowel cancer (colorectal cancer) is the 4th most common cancer in Scotland. Approximately 4,000 cases are diagnosed annually. Cancer-related deaths in Scotland are higher than other UK nations. Improving the early detection of bowel cancer, and therefore survival, is important. The majority of bowel cancers are diagnosed within secondary-care (colorectal surgery unit). Upon GP referral to secondary-care, patients provide stool samples which are analysed for microscopic blood (FIT; faecal immunohistochemical test). Patients with a single positive result are more likely to have bowel cancer (0.2% risk if no blood detected, but 8.4% if detected). A positive test triggers further investigation, either CT scan or colonoscopy depending on the result. Currently, colonoscopy and radiology services throughout Scotland are under significant pressure causing delays. Only 2% of patients referred to secondary-care are diagnosed with bowel cancer, and most colonoscopies performed do not yield significant findings. We have shown that performing two repeated FITs upon referral improves cancer pick-up rate (sensitivity) and reduces missed cancers. We successfully implemented this in NHS Lothian and contributed to national guidelines. Optimising allocation of investigations and therefore improving the detection-rate (specificity) may reduce colonoscopy demand, saving vital resources. NHS Lothian patients referred to secondary-care with symptoms concerning of bowel cancer will be included. \~1,000 included patients will undertake extra FIT tests in study whether changes in stool blood levels over time help better allocate investigations and improve test specificity. With these results, a new secondary-care pathway will be designed. Health economic analysis will determine costs and benefits of implementing a new pathway and the risks of missed cancers. The project also provides infrastructure to collect additional stool and blood samples to develop new tests that improve bowel cancer detection.

Key Dates

First listed
Feb 24, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Mar 22, 2028
Completion
Mar 22, 2037

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Additional FIT testing
    Additional (3) FITs

Primary Outcome Measure

Pathway diagnostic accuracy [ Time Frame: One year ]

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